Product Code: IYE FDA class 2 21 CFR 892.5050

Accelerator, Linear, Medical

Radiology

A medical linear accelerator is a device used in radiation therapy to deliver high-energy X-ray or electron beams for the treatment of cancer and other tumors. It falls under FDA Class 2, indicating moderate risk; manufacturers must submit a 510(k) premarket notification demonstrating substantial equivalence to a legally marketed predicate device before marketing. The product code is IYE, regulated under 21 CFR 892.5050, within the Radiology medical specialty. No special flags apply to this device.

View on FDA

510(k)s

718

FEI Numbers

123

Registration Numbers

124

Unique Applicants

270

Years Active

Basic Information

Product Code: IYE
Device Class: FDA class 2
Regulation Number: 892.5050
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 718 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243142	Cranial 4Pi Immobilization	Jun 23, 2025	Substantially Equivalent	Brainlab AG
K243301	MapRT	May 19, 2025	Substantially Equivalent	Vision RT Ltd
K250099	Mobius3D (4.1)	May 16, 2025	Substantially Equivalent	Varian Medical Systems
K250429	DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set	Mar 19, 2025	Substantially Equivalent	MacroMedics BV
K241937	Klarity SGRT System (ARSG-E1A, ARSG-E3A)	Mar 18, 2025	Substantially Equivalent	Klarity Medical & Equipment (GZ) Co., Ltd.
K242957	Identify (4.0)	Feb 07, 2025	Substantially Equivalent	Varian Medical Systems, Inc.
K240431	ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface	Jul 24, 2024	Substantially Equivalent	Brainlab AG
K232738	BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)	May 31, 2024	Substantially Equivalent	PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
K232923	Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)	Apr 30, 2024	Substantially Equivalent	Varian Medical Systems Inc.
K232489	VenusX	Apr 12, 2024	Substantially Equivalent	LinaTech LLC
K233622	AlignRT Plus	Mar 29, 2024	Substantially Equivalent	Vision RT Ltd
K232031	LUNA 3D	Mar 29, 2024	Substantially Equivalent	LAP GmbH Laser Applikationen
K231573	ThinkQA (Edition 2)	Jan 18, 2024	Substantially Equivalent	DOSIsoft SA
K223234	Delta4 Insight	Jan 16, 2024	Substantially Equivalent	ScandiDos AB
K231273	ArcherQA (V1.0)	Jan 05, 2024	Substantially Equivalent	Wisdom Technologies., Inc.
K232293	kallisio stentra oral stent	Dec 22, 2023	Substantially Equivalent	Kallisio, Inc
K232870	TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)	Dec 21, 2023	Substantially Equivalent	Varian Medical Systems, Inc
K231852	BinkieRT	Nov 15, 2023	Substantially Equivalent	Papricalab
K232113	Halcyon, Ethos Radiotherapy System	Nov 03, 2023	Substantially Equivalent	Varian Medical Systems Inc.
K231317	TrueBeam, TrueBeam STx, Edge, VitalBeam	Sep 12, 2023	Substantially Equivalent	Varian Medical Systems, Inc.
K230576	IDENTIFY	Jul 25, 2023	Substantially Equivalent	Varian Medical Systems Inc.
K223834	AccuCheck	Jul 20, 2023	Substantially Equivalent	Manteia Technologies Co., Ltd.
K231185	MapRT	Jun 23, 2023	Substantially Equivalent	Vision RT Ltd
K223159	Radixact Treatment Delivery System	Jun 23, 2023	Substantially Equivalent	Accuray Incorporated
K222762	SIDDHARTH-II;IMPACT	Jun 08, 2023	Substantially Equivalent	Panacea Medical Technologies Pvt Ltd
K223839	TrueBeam, TrueBeam STx, Edge, VitalBeam	May 22, 2023	Substantially Equivalent	Varian Medical Systems, Inc.
K231052	ExacTrac Dynamic 1.1.2	May 11, 2023	Substantially Equivalent	Brainlab AG
K230699	ARIA Radiation Therapy Management (v18.0)	Apr 10, 2023	Substantially Equivalent	Varian Medical Systems Inc.
K230312	Iris AirShuttle	Mar 31, 2023	Substantially Equivalent	Qfix
K223229	MOSAIQ® OIS (Oncology Information System)	Feb 23, 2023	Substantially Equivalent	Elekta Solutions AB
K223209	Elekta Unity	Feb 23, 2023	Substantially Equivalent	Elekta Solutions AB
K222977	DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip	Feb 17, 2023	Substantially Equivalent	MacroMedics BV
K222941	Halcyon, Ethos Radiotherapy System	Jan 17, 2023	Substantially Equivalent	Varian Medical Systems, Inc
K220539	Klarity SRS Baseplate, Klarity Promise Baseplate	Nov 01, 2022	Substantially Equivalent	Klarity Medical & Equipment (GZ) Co., Ltd.
K220583	ClearCheck Model RADCC V2	Aug 23, 2022	Substantially Equivalent	Radformation, Inc.
K213439	FlexBoardTM, EagleBoardTM, BreastBoard SXTM	Jun 24, 2022	Substantially Equivalent	MacroMedics BV
K221408	ARIA Radiation Therapy Management (v16.1 MR3)	Jun 17, 2022	Substantially Equivalent	Varian Medical Systems, Inc
K221448	ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)	Jun 15, 2022	Substantially Equivalent	Varian Medical Systems, Inc
K213977	TrueBeam, TrueBeam STx, Edge, VitalBeam	Jun 03, 2022	Substantially Equivalent	Varian Medical Systems, Inc.
K213137	INTDose	May 13, 2022	Substantially Equivalent	Carina Medical LLC
K212909	VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips	May 11, 2022	Substantially Equivalent	MacroMedics BV
K213526	Aurora-RT	May 04, 2022	Substantially Equivalent	MagnetTx Oncology Solutions Ltd.
K220338	ExacTrac Dynamic	Apr 29, 2022	Substantially Equivalent	Brainlab AG
K213370	VERIQA	Mar 30, 2022	Substantially Equivalent	PTW-Freiburg Physikalisch-Technische-Werkstaetten
K213053	Gold Anchor	Jan 06, 2022	Substantially Equivalent	Naslund Medical AB
K212958	MRIdian Linac System	Dec 14, 2021	Substantially Equivalent	ViewRay, Incorporated
K212583	AlignRT Plus	Nov 10, 2021	Substantially Equivalent	Vision RT Ltd
K210921	TaiChiB	Nov 02, 2021	Substantially Equivalent	Our United Corporation
K212114	Elekta Unity	Oct 01, 2021	Substantially Equivalent	Elekta Solutions AB
K212794	Accuray Precision Treatment Planning System	Sep 30, 2021	Substantially Equivalent	Accuray Incorporated
K211760	Panther OIS	Sep 28, 2021	Substantially Equivalent	Prowess Inc.
K210894	SIDDHARTH-II; IMPACT	Sep 28, 2021	Substantially Equivalent	Panacea Medical Technologies Pvt.Ltd
K212606	BeamSite	Sep 15, 2021	Substantially Equivalent	DoseOptics LLC
K203722	RayPilot System	Sep 02, 2021	Substantially Equivalent	Micropos Medical AB
K212294	Ethos Treatment Management, Ethos Treatment Planning	Aug 20, 2021	Substantially Equivalent	Varian Medical Systems, Inc.
K211663	Zap-X Radiosurgical System	Jul 29, 2021	Substantially Equivalent	Zap Surgical Systems, Inc.
K211939	ExacTrac Dynamic	Jul 22, 2021	Substantially Equivalent	Brainlab AG
K210500	Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD	Jun 11, 2021	Substantially Equivalent	Elekta Limited
K211590	Fiducial Marker	Jun 10, 2021	Substantially Equivalent	Carbon Medical Technologies Inc.
K211001	C-Qual M Breastboard; Monarch Overhead Arm Positioner	May 20, 2021	Substantially Equivalent	MEDTEC, Inc. dba CIVCO Medical Solutions and CIVCO
K202747	Klarity Bolus	May 14, 2021	Substantially Equivalent	Klarity Medical & Equipment (GZ) Co., Ltd.
K210835	Identify	Apr 20, 2021	Substantially Equivalent	Varian Medical Systems Inc.
K203387	AlignRT Plus	Mar 04, 2021	Substantially Equivalent	Vision RT Ltd
K203669	Mobius3D	Jan 14, 2021	Substantially Equivalent	Varian Medical Systems, Inc.
K203172	MOSAIQ Oncology Information System	Dec 18, 2020	Substantially Equivalent	Elekta Solutions AB
K202412	ClearRT Helical kVCT for the Radixact Treatment Delivery System	Dec 18, 2020	Substantially Equivalent	Accuray Incorporated
K200940	BeamSite	Dec 11, 2020	Substantially Equivalent	DoseOptics LLC
K203173	ExacTrac Dynamic	Nov 12, 2020	Substantially Equivalent	Brainlab AG
K202050	Cranial 4Pi Immobilization	Aug 19, 2020	Substantially Equivalent	Brainlab AG
K202068	The AIO Solution 3.0	Aug 14, 2020	Substantially Equivalent	Orfit Industries NV
K193207	TaiChiA	Aug 07, 2020	Substantially Equivalent	Our United Corporation
K201276	ExacTrac Dynamic	Jul 13, 2020	Substantially Equivalent	Brainlab AG
K200652	Lollipop BiteBlock	Jul 06, 2020	Substantially Equivalent	RadTec Medical Devices, Inc.
K201119	ChartCheck	Jun 26, 2020	Substantially Equivalent	Radformation, Inc.
K201117	Gold Anchor	Jun 11, 2020	Substantially Equivalent	Naslund Medical AB
K200907	Thales 3D Mr Scanner	Jun 03, 2020	Substantially Equivalent	LAP GmbH Laser Applikationen
K200435	Catalyst+, Catalyst+ HD	May 07, 2020	Substantially Equivalent	C-Rad Positioning AB
K192405	Image Guidance System for Radiotherapy	May 01, 2020	Substantially Equivalent	Jiangsu Rayer Medical Technology Co., Ltd.
K200600	Sentinel	Apr 20, 2020	Substantially Equivalent	C-Rad Positioning AB
K190978	RefleXion Medical Radiotherapy System	Mar 12, 2020	Substantially Equivalent	RefleXion Medical, Inc.
K193243	Alta Multipurpose Device	Feb 28, 2020	Substantially Equivalent	Qfix
K191646	Beamscan MR	Feb 21, 2020	Substantially Equivalent	PTW-Freiburg Physikalisch-Technische-Werkstaetten
K192377	Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon	Feb 10, 2020	Substantially Equivalent	Varian Medical Systems, Inc.
K193431	AlignRT Plus	Jan 03, 2020	Substantially Equivalent	Vision RT Ltd
K192196	Medical Radiation Dosimetry System microSTARii	Dec 27, 2019	Substantially Equivalent	Landauer
K192482	Elekta Unity	Dec 05, 2019	Substantially Equivalent	Elekta Limited
K192242	Synergy Platform, Synergy, Infinity, VersaHD	Nov 22, 2019	Substantially Equivalent	Elekta Limited
K192968	IDENTIFY	Nov 12, 2019	Substantially Equivalent	Varian Medical Systems, Inc.
K191944	MU2net	Oct 24, 2019	Substantially Equivalent	DOSIsoft
K192424	Mobius3D	Oct 03, 2019	Substantially Equivalent	Varian Medical Systems, Inc
K192102	Thermoplastic Masks	Sep 25, 2019	Substantially Equivalent	Aktina Medical Corporation
K191158	The AIO Solution	Aug 06, 2019	Substantially Equivalent	Orfit Industries NV
K191267	ImagingRing System on Rails	Aug 01, 2019	Substantially Equivalent	MedPhoton GmbH
K191761	Mobius3D	Jul 31, 2019	Substantially Equivalent	Varian Medical Systems, Inc
K191797	BiomarC Fiducial Marker	Jul 29, 2019	Substantially Equivalent	Carbon Medical Technologies
K190137	Identify	Jul 10, 2019	Substantially Equivalent	Varian Medical Systems Inc.
K182374	LIAC S	May 22, 2019	Substantially Equivalent	Sit Sordina Iort Technologies Spa
K190894	TOTIM Patient Cushion Immobilization System	Apr 30, 2019	Substantially Equivalent	Essebi Medical SRL
K183606	Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)	Apr 08, 2019	Substantially Equivalent	ScandiDos AB
K190155	FibermarX Radiopaque Tissue Marker	Feb 27, 2019	Substantially Equivalent	Viscus Biologics, LLC
K183374	GrayDuck Stent	Feb 26, 2019	Substantially Equivalent	POLL Medical LLC
K183698	Zap-X Radiosurgery System	Feb 25, 2019	Substantially Equivalent	Zap Surgical Systems
K181989	MRIdian Linac System	Feb 20, 2019	Substantially Equivalent	ViewRay, Incorporated
K183034	MOSAIQ Oncology Information System	Dec 04, 2018	Substantially Equivalent	Elekta, Inc
K182076	Elekta Unity	Dec 04, 2018	Substantially Equivalent	Elekta Limited
K182687	Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System	Nov 23, 2018	Substantially Equivalent	ACCURAY INCORPORATED
K182189	Encompass SRS Headframe ; Encompass MR SRS Headframe	Oct 04, 2018	Substantially Equivalent	Qfix
K182050	Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch	Oct 03, 2018	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K173926	DORADOnova MR3T	Sep 14, 2018	Substantially Equivalent	LAP GmbH Laser Applikationen
K182079	Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask	Sep 07, 2018	Substantially Equivalent	MEDTEC Inc. dba CIVCO Medical Solutions
K182138	Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD	Sep 05, 2018	Substantially Equivalent	Eleckta Limited
K181218	AlignRT Plus	Aug 07, 2018	Substantially Equivalent	Vision RT Ltd
K173848	Model WP-3840 and WP-3040	Aug 07, 2018	Substantially Equivalent	CNMC Co., Inc.
K180027	ACCUSYTE 3D Fiducial Marker	Jul 18, 2018	Substantially Equivalent	Radiation Products LLC
K180697	Pseudo-Patient	Jul 10, 2018	Substantially Equivalent	RTsafe, Inc.
K180021	Proton Positioing and Immobilization Devices	Jun 29, 2018	Substantially Equivalent	MEDTEC Inc dba CIVCO Medical Solutions and CIVCO Radiotherap
K181404	Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator	Jun 28, 2018	Substantially Equivalent	Varian Medical Systems, Inc.
K172961	LIAC HWL	Jun 11, 2018	Substantially Equivalent	Sit Sordina Iort Technologies Spa
K181032	Halcyon	May 09, 2018	Substantially Equivalent	Varian Medical Systems Inc.
K170570	Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung	Apr 06, 2018	Substantially Equivalent	Varian Medical Systems Inc
K180595	SciMoCa	Apr 04, 2018	Substantially Equivalent	Radialogica LLC
K180586	Varian Head Frame	Apr 02, 2018	Substantially Equivalent	Varian Medical Systems, Inc.
K180106	ThinkQA	Mar 13, 2018	Substantially Equivalent	DOSIsoft
K173838	ARIA Radiation Therapy Management	Jan 17, 2018	Substantially Equivalent	Varian Medical Systems, Inc.
K173251	LumiCoil Platinum Fiducial Marker	Dec 19, 2017	Substantially Equivalent	Boston Scientific Corporation
K171352	EZFluence	Dec 01, 2017	Substantially Equivalent	Radformation, Inc.
K171350	Collision Check	Nov 29, 2017	Substantially Equivalent	Radformation, Inc.
K171467	BioZorb Marker GOLD / LP Marker GOLD	Nov 09, 2017	Substantially Equivalent	Focal Therapeutics
K172534	LINACwatch, LinacView	Oct 27, 2017	Substantially Equivalent	QualiFormeD Sarl
K170345	SOFTDISO	Oct 27, 2017	Substantially Equivalent	Best Nomos
K170307	SunCHECK	Oct 25, 2017	Substantially Equivalent	SUN NUCLEAR CORPORATION
K160405	OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D	Oct 20, 2017	Substantially Equivalent	PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN
K171804	Zap-X Radiosurgery System	Sep 21, 2017	Substantially Equivalent	Zap Surgical Systems
K172013	VitalBeam	Jul 28, 2017	Substantially Equivalent	Varian Medical Systems, Inc.
K171837	TomoTherapy Treatment Delivery System with iDMS	Jul 25, 2017	Substantially Equivalent	Accuray Incorporated
K171734	HP PRO Positioning Device	Jul 25, 2017	Substantially Equivalent	Orfit Industries NV
K171733	TrueBeam, TrueBeam STx, Edge	Jul 12, 2017	Substantially Equivalent	Varian Medical Systems, Inc.
K171133	Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories	Jul 11, 2017	Substantially Equivalent	Qfix
K170817	Halcyon	Jun 27, 2017	Substantially Equivalent	Varian Medical Systems Inc.
K171086	Accuray Precision Treatment Planning System	Jun 08, 2017	Substantially Equivalent	Accuray Incorporated
K170751	MRIdian Linac System with 138-leaf Collimator	Jun 07, 2017	Substantially Equivalent	ViewRay Incorporated
K161807	BEAMSCAN	May 19, 2017	Substantially Equivalent	PTW-Freiburg Physikalisch Technische-Werksraetten
K161724	Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)	Apr 28, 2017	Substantially Equivalent	RadioMed Corporation
K170788	CyberKnife Treatment Delivery System	Apr 11, 2017	Substantially Equivalent	Accuray Incorportaed
K170058	TheraView TBI	Mar 03, 2017	Substantially Equivalent	Cablon Medical B.V.
K162393	The ViewRay (MRIdian) Linac System	Feb 24, 2017	Substantially Equivalent	VIEWRAY INCORPORATED
K162472	TrueBeam-TrueBeam STx-Edge	Jan 19, 2017	Substantially Equivalent	Varian Medical Systems, Inc.
K162476	Varian High Energy Linear Accelerator	Dec 12, 2016	Substantially Equivalent	Varian Medical Systems, Inc.
K161400	ImagingRing System	Dec 08, 2016	Substantially Equivalent	MEDPHOTON GMBH
K162468	ClearCheck	Dec 01, 2016	Substantially Equivalent	RADFORMATION
K162355	Raycast MammoRx Carbon Fibre Breast Board	Nov 22, 2016	Substantially Equivalent	Orfit Industries NV
K162577	Dosimetry Check Version 5 Release 1	Nov 18, 2016	Substantially Equivalent	MATH RESOLUTIONS, LLC
K162265	CushionCast Moldable Cushions	Nov 15, 2016	Substantially Equivalent	IZI Medical Products LLC
K162862	Raycast High Precision Lung Board Solution	Nov 09, 2016	Substantially Equivalent	Orfit Industries NV
K162002	Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay	Nov 01, 2016	Substantially Equivalent	ZDi, Solutions, LLC
K162629	IQM Integral Quality Monitor (also IQM)	Oct 20, 2016	Substantially Equivalent	IRT SYSTEMS
K161984	Interlocked Circular Small Field Collimators, Elekta Integrated	Sep 27, 2016	Substantially Equivalent	AKTINA MEDICAL CORPORATION
K161946	DoseCHECK	Sep 16, 2016	Substantially Equivalent	Sun Nuclear Corporation
K161146	Radixact Treatment Delivery System	Jun 24, 2016	Substantially Equivalent	ACCURAY INCORPORATED
K161144	iDMS Data Management System	Jun 24, 2016	Substantially Equivalent	ACCURAY INCORPORATED
K160209	Gold Anchor	Jun 21, 2016	Substantially Equivalent	NASLUND MEDICAL AB
K160627	Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution	Jun 14, 2016	Substantially Equivalent	QFIX
K153026	Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement	May 25, 2016	Substantially Equivalent	MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
K160057	ArcCHECK-MR	May 13, 2016	Substantially Equivalent	Sun Nuclear Corporation
K153014	Mobius3D	Apr 29, 2016	Substantially Equivalent	MOBIUS MEDICAL SYSTEMS, LP
K153270	TruGuard Custom Tongue and Jaw Positioner	Mar 08, 2016	Substantially Equivalent	BIONIX DEVELOPMENT CORP.
K152994	Adaptivo	Feb 03, 2016	Substantially Equivalent	Aurora Technology Development, LLC
K151426	ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+	Jan 29, 2016	Substantially Equivalent	SCANDIDOS AB
K153011	iViewDose R1.0	Dec 11, 2015	Substantially Equivalent	Elekta Limited
K152321	kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening	Dec 04, 2015	Substantially Equivalent	QFIX
K152761	Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)	Nov 25, 2015	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K142617	ArcCHECK	Nov 20, 2015	Substantially Equivalent	SUN NUCLEAR CORPORATION
K151946	Thermofit	Nov 09, 2015	Substantially Equivalent	ORFIT INDUSTRIES
K151882	Varian Treatment (VTx)	Oct 26, 2015	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K152867	MHI-TM2000 Linear Accelerator System, VERO, Imavis	Oct 21, 2015	Substantially Equivalent	MITSUBISHI HEAVY INDUSTRIES, LTD.
K143560	CygneX I System	Oct 05, 2015	Substantially Equivalent	Accuthera Inc.
K150382	Radio Therapy Treatment Chair	Sep 16, 2015	Substantially Equivalent	RADIATION PRODUCTS DESIGN, INC.
K150265	Model 206 Electrometer/Dosimeter	Sep 03, 2015	Substantially Equivalent	CNMC COMPANY INCORPORATED
K151180	ScandiDos Delta4 Phantom+	Aug 19, 2015	Substantially Equivalent	SCANDIDOS AB
K150767	EDOSE	Aug 17, 2015	Substantially Equivalent	GUANGZHOU RAYDOSE SOFTWARE TECHNOLOGY., LLC
K151207	Proton Immobilization Solution	Jul 28, 2015	Substantially Equivalent	ORFIT INDUSTRIES NV
K150873	CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System	Jul 01, 2015	Substantially Equivalent	ACCURAY INCORPORATED
K150848	Dose Calculator	May 20, 2015	Substantially Equivalent	SUN NUCLEAR CORPORATION
K151097	Active Breathing Coordinator	May 15, 2015	Substantially Equivalent	AKTINA MEDICAL CORPORATION
K150706	VitalBeam	May 08, 2015	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K142420	Patient Positioning Devices	Mar 27, 2015	Substantially Equivalent	MACROMEDICS BV
K142294	FlexiMarc Marker	Mar 26, 2015	Substantially Equivalent	CORTEX MANUFACTURING, INC.
K143485	iGuide 2.1	Mar 04, 2015	Substantially Equivalent	MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
K143224	TrueBeam-TrueBeam STx-Edge	Dec 19, 2014	Substantially Equivalent	Varian Medical Systems, Inc.
K142560	Varian Head Frame	Dec 11, 2014	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K142431	WaterProof PROFILER	Dec 05, 2014	Substantially Equivalent	SUN NUCLEAR CORPORATION
K142142	QUALITY REPORTS	Dec 05, 2014	Substantially Equivalent	SUN NUCLEAR CORPORATION
K142434	ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1	Nov 21, 2014	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K141855	CLARITY	Oct 08, 2014	Substantially Equivalent	ELEKTA LTD.
K142268	Varian Verification System (VVS)	Oct 02, 2014	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K141800	PERFRACTION	Sep 26, 2014	Substantially Equivalent	SUN NUCLEAR CORPORATION
K141572	MOSAIQ ONCOLOGY INFORMATION SYSTEM	Sep 05, 2014	Substantially Equivalent	IMPAC MEDICAL SYSTEMS, INC.
K140528	TRUE BEAM, TRUE BEAM STX, EDGE	Sep 05, 2014	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K141230	DOSELAB PRO	Aug 27, 2014	Substantially Equivalent	MOBIUS MEDICAL SYSTEMS, LP
K141787	SAGITTILT	Aug 07, 2014	Substantially Equivalent	ORFIT INDUSTRIES NV
K140823	PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER	Jun 27, 2014	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K140660	MOBIUS3D	Jun 24, 2014	Substantially Equivalent	MOBIUS MEDICAL SYSTEMS, LP
K133572	ARIA RADIATION THERAPY MANAGEMENT	Apr 04, 2014	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K133227	SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING	Mar 14, 2014	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K132908	TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT	Mar 04, 2014	Substantially Equivalent	MEDTEC, INC.
K132064	BIOMARC FIDUCIAL MARKER	Feb 28, 2014	Substantially Equivalent	CARBON MEDICAL TECHNOLOGIES, INC.
K132935	ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME	Feb 21, 2014	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K133240	VARIAN MULTILEAF COLLIMATOR	Jan 31, 2014	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K132605	DOSIMETRY CHECK VERSION 4 RELEASE 1	Nov 14, 2013	Substantially Equivalent	MATH RESOLUTIONS, LLC.
K132124	KLARITY VACUUM BAG, KLARITY MOLD CUSHION	Nov 01, 2013	Substantially Equivalent	KLARITY MEDICAL PRODUCTS, LLC
K132705	UNIQUE	Oct 31, 2013	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K131807	HIGH ENERGY LINEAR ACCELERATOR	Oct 11, 2013	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K131795	NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS	Sep 26, 2013	Substantially Equivalent	ORFIT INDUSTRIES NV
K131965	XVI R5.0	Sep 25, 2013	Substantially Equivalent	Elekta Limited
K131862	3DVH	Aug 21, 2013	Substantially Equivalent	SUN NUCLEAR CORPORATION
K131466	MAPCHECK2, ARCCHECK	Aug 20, 2013	Substantially Equivalent	SUN NUCLEAR CORPORATION
K131313	ACTIVE BREATHING COORDINATOR	Aug 07, 2013	Substantially Equivalent	AKTINA MEDICAL CORP.
K131704	EPIDOSE	Aug 05, 2013	Substantially Equivalent	SUN NUCLEAR CORPORATION
K130992	PINNACLE3 RADIATION THERAPY PLANNING SYSTEM	Jun 14, 2013	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K121284	CHABNER XRT GARMENTS	Jun 14, 2013	Substantially Equivalent	BFFL CO. INC
K122888	CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM	Apr 30, 2013	Substantially Equivalent	CDR SYSTEMS, INC.
K130678	BIOMARC GOLD FIDUCIAL MARKER	Apr 12, 2013	Substantially Equivalent	CARBON MEDICAL TECHNOLOGIES, INC.
K123808	AGILITY	Apr 04, 2013	Substantially Equivalent	ELEKTA LTD.
K123812	COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV	Mar 01, 2013	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K123788	INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)	Jan 15, 2013	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K123371	ALIGNRT PLUS	Jan 08, 2013	Substantially Equivalent	VISION RT LIMITED
K122616	PANTHER OIS/R & V MODEL VERSION 2.0	Dec 21, 2012	Substantially Equivalent	PROWESS, INC.
K123291	TRUEBEAM	Dec 20, 2012	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K123230	MOSAIQ ONCOLOGY INFORMATION SYSTEM	Dec 12, 2012	Substantially Equivalent	IMPAC MEDICAL SYSTEMS, INC.
K123137	CALYPSO SYSTEM	Dec 05, 2012	Substantially Equivalent	VARIAN MEDICAL SYSTEMS
K121663	CLARITY	Dec 05, 2012	Substantially Equivalent	ELEKTA LTD.
K122137	CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM	Oct 26, 2012	Substantially Equivalent	ACCURAY INCORPORATED
K121657	PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR	Oct 23, 2012	Substantially Equivalent	PROTON SYSTEMS
K121845	SDX SYSTEM	Oct 19, 2012	Substantially Equivalent	DYN'R SAS
K122450	MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS	Oct 03, 2012	Substantially Equivalent	MITSUBISHI HEAVY INDUSTRIES, LTD.
K122451	EXACTRAC VERO	Sep 28, 2012	Substantially Equivalent	BRAINLAB AG
K121934	TOMOTHERAPY TREATMENT SYSTEM	Aug 29, 2012	Substantially Equivalent	ACCURAY INCORPORATED
K120789	EXACTRAC X-RAY X-RAY	Aug 14, 2012	Substantially Equivalent	BRAINLAB AG
K112692	IDENTIFY	Aug 03, 2012	Substantially Equivalent	HUMEDIQ GMBH
K120668	SENTINEL	Jul 30, 2012	Substantially Equivalent	C-RAD POSITIONING AB
K121295	ARTISTETM SOLUTION WITH SYS VCIO	Jun 27, 2012	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K121530	BODYFIX SYSTEM	Jun 20, 2012	Substantially Equivalent	MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
K121328	AGILITY	Jun 12, 2012	Substantially Equivalent	ELEKTA LTD.
K111862	VIEWRAY SYSTEM	May 22, 2012	Substantially Equivalent	VIEWRAY INCORPORATED
K120335	EMBRACE THERMOPLASTIC	May 03, 2012	Substantially Equivalent	BIONIX DEVELOPMENT CORP.
K112286	NOVAC 11	Apr 19, 2012	Substantially Equivalent	NEW RADIANT TECHNOLOGY S.P.A.
K110840	LIAC	Apr 17, 2012	Substantially Equivalent	SORDINA S.P.A.
K120233	SYNCHRONY RESPIRATORY TRACKING SYSTEM	Mar 09, 2012	Substantially Equivalent	ACCURAY INCORPORATED
K120067	MOSAIQ ONCOLOGY INFORMATION SYSTEM	Feb 28, 2012	Substantially Equivalent	IMPAC MEDICAL SYSTEMS, INC.
K113276	CATALYST	Feb 27, 2012	Substantially Equivalent	C-RAD POSITIONING AB
K112841	SURFACE BEACON TRANSPONDERS	Feb 16, 2012	Substantially Equivalent	CALYPSO MEDICAL TECHNOLOGIES INC
K111332	CLARITY OBP SYSTEM	Jan 30, 2012	Substantially Equivalent	ELEKTA LTD.
K113758	VOLUSON E6/E8/E8EXPERT/E10	Jan 10, 2012	Substantially Equivalent	GE HEALTHCARE
K110971	TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT	Jan 10, 2012	Substantially Equivalent	NAVOTEK MEDICAL LTD
K112778	SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING	Dec 29, 2011	Substantially Equivalent	VARIAN MEDICAL SYSTEMS
K112613	INTEGRITY(TM)	Dec 16, 2011	Substantially Equivalent	Elekta Limited
K112210	FRAXION	Nov 22, 2011	Substantially Equivalent	MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
K112839	VARIAN HIGH ENERGY LINEAR ACCELERATOR	Nov 14, 2011	Substantially Equivalent	VARIAN MEDICAL SYSTEMS
K112460	MULTIPLE	Oct 07, 2011	Substantially Equivalent	LARSON MEDICAL PRODUCTS, INC.
K111106	TRUEBEAM	Aug 18, 2011	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K110772	BIOMARC FIDUCIAL MARKER	Apr 28, 2011	Substantially Equivalent	CARBON MEDICAL TECHNOLOGIES, INC.
K103606	ARTISTE SOLUTION WITH SYS_VB50 UPDATE	Apr 15, 2011	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K103616	PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER	Jan 25, 2011	Substantially Equivalent	AKTINA MEDICAL PHYSICS CORP.
K100625	REALEYE MODEL VCPS	Jan 21, 2011	Substantially Equivalent	NAVOTEK MEDICAL LTD
K103394	BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)	Jan 12, 2011	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
K103193	DOSEVIEW 3D	Dec 27, 2010	Substantially Equivalent	STANDARD IMAGING, INC.
K102765	PRONEX	Dec 07, 2010	Substantially Equivalent	DIREX SYSTEMS CORP.
K102237	PVS MODEL 1.0	Nov 23, 2010	Substantially Equivalent	MEDCOM GMBH
K102650	CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	Nov 17, 2010	Substantially Equivalent	ACCURAY INCORPORATED
K102200	INTEGRITY MODEL 1014284	Nov 04, 2010	Substantially Equivalent	ELEKTA LTD.
K102583	MUCHECK, VERSION 9.0	Nov 02, 2010	Substantially Equivalent	ONCOLOGY DATA SYSTEMS, INC.
K102024	RPM RESPIRATORY GATING SYSTEM	Oct 15, 2010	Substantially Equivalent	VARIAN MEDICAL SYSTEMS
K102671	SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2	Oct 12, 2010	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K101992	3D SCANNER, MODEL 1230	Oct 01, 2010	Substantially Equivalent	SUN NUCLEAR CORP.
K101751	VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR	Aug 10, 2010	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
K101503	DUSIMETRY CHECK	Aug 04, 2010	Substantially Equivalent	MATH RESOLUTIONS, LLC.
K100890	VARIAN HIGH ENERGY LINEAR ACCELERATOR	Jul 13, 2010	Substantially Equivalent	VARIAN MEDICAL SYSTEMS
K093967	VARIAN TREATMENT	Jul 12, 2010	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K100801	PUMA MODEL VERSION 1.0	Jun 18, 2010	Substantially Equivalent	PROWESS, INC.
K101131	FIDUCIAL MARKERS	Jun 17, 2010	Substantially Equivalent	COSMAN MEDICAL, INC.
K100691	OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500	May 11, 2010	Substantially Equivalent	BIONIX DEVELOPMENT CORP.
K100096	LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART	Apr 22, 2010	Substantially Equivalent	INTEGRA RADIONICS, INC.
K100264	T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060	Apr 09, 2010	Substantially Equivalent	BIONIX DEVELOPMENT CORP.
K100115	XVI R4.5	Mar 10, 2010	Substantially Equivalent	ELEKTA LTD.
K092424	P-ART, MODEL 001	Mar 05, 2010	Substantially Equivalent	P-CURE LTD
K100267	FLEXIMARC, MODEL CM-0.9-2-10-GG-L	Feb 24, 2010	Substantially Equivalent	CORTEX MANUFACTURING, INC.
K092845	RESPISENS	Jan 26, 2010	Substantially Equivalent	NOMICS
K092479	SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL	Jan 11, 2010	Substantially Equivalent	DYN'R
K093527	ARIA RADIATION ONCOLOGY WITH MIRS	Dec 15, 2009	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K092550	TIGRT IVS	Dec 15, 2009	Substantially Equivalent	LINATECH, LLC
K092871	TRILOGY MX	Nov 30, 2009	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K092939	PATLOG 2.0	Oct 09, 2009	Substantially Equivalent	ONCOLOG MEDICAL QA AB
K092041	STELLAR FIDUCIAL MARKER, MODEL GFMIA	Oct 02, 2009	Substantially Equivalent	STELLAR MEDICAL LLC.
K092145	160MLC OPTION	Sep 18, 2009	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K092018	OMNIPRO INCLINE	Sep 18, 2009	Substantially Equivalent	IBA DOSIMETRY GMBH
K091999	CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	Sep 18, 2009	Substantially Equivalent	ACCURAY, INC.
K092019	MODEL 1014 PC ELECTROMETER	Sep 15, 2009	Substantially Equivalent	SUN NUCLEAR CORP.
K092285	PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90	Aug 28, 2009	Substantially Equivalent	BEST MEDICAL CANADA LTD.
K091645	GOLD ANCHOR	Jul 21, 2009	Substantially Equivalent	NASLUND MEDICAL AB
K090802	TIGRT MLC, TIGRT DMLC	Jul 07, 2009	Substantially Equivalent	LINATECH, LLC
K091209	PORTALVISION ADVANCED IMAGING	Jun 23, 2009	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K091602	MUCHECK V8	Jun 18, 2009	Substantially Equivalent	ONCOLOGY DATA SYSTEMS, INC.
K091132	4D INTEGRATED TREATMENT CONSOLE	Jun 17, 2009	Substantially Equivalent	VARIAN MEDICAL SYSTEMS
K090683	SYNGO RT THERAPIST CONNECT	May 08, 2009	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K082582	SENTINEL, MODEL SP-001	Mar 30, 2009	Substantially Equivalent	C-RAD POSITIONING AB
K090349	CLEARVUE PRONE BREAST TREATMENT TABLE	Mar 09, 2009	Substantially Equivalent	ORBITAL THERAPY, LLC
K082775	PRESCISION OPTION	Feb 19, 2009	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K090044	PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C	Jan 22, 2009	Substantially Equivalent	ONCOLOG MEDICAL QA AB
K082909	RSVP HALF SPHERE PHANTOM, MODEL DDP010	Dec 23, 2008	Substantially Equivalent	THE PHANTOM LABORATORY, INC.
K082773	STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331	Nov 19, 2008	Substantially Equivalent	STANDARD IMAGING, INC.
K081935	STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100	Oct 07, 2008	Substantially Equivalent	AKTINA MEDICAL PHYSICS CORP.
K082122	MLCI2	Aug 29, 2008	Substantially Equivalent	ELEKTA LTD.
K081859	MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM	Aug 04, 2008	Substantially Equivalent	SICEL TECHNOLOGIES, INC.
K081760	RSVP PHANTOM PELVIS, MODEL TLP260	Jul 29, 2008	Substantially Equivalent	THE PHANTOM LABORATORY, INC.
K081218	BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST	Jul 21, 2008	Substantially Equivalent	IT-V MEDIZINTECHNIK, GMBH
K081188	TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE	Jul 14, 2008	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K080585	DESKTOP PRO	Jun 11, 2008	Substantially Equivalent	ELEKTA LTD.
K080072	MRI PATIENT POSITIONING DEVICES	Jun 04, 2008	Substantially Equivalent	CIVCO MEDICAL INSTRUMENTS CO., INC.
K080726	CALYPSO 4D LOCALIZATION SYSTEM	May 14, 2008	Substantially Equivalent	CALYPSO MEDICAL TECHNOLOGIES INC
K081036	4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS)	May 09, 2008	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K080742	VERISUITE 1.6, VERISUITE-PARTICLE 1.6	May 09, 2008	Substantially Equivalent	MEDCOM GMBH
K073018	STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT	Jan 23, 2008	Substantially Equivalent	BRAINLAB AG
K072485	ARTISTE MV SA	Dec 27, 2007	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K073273	EQUAL DOSE 1.0	Dec 11, 2007	Substantially Equivalent	NUCLETRON CORPORATION
K072374	COMPASS	Dec 07, 2007	Substantially Equivalent	SCANDITRONIX WELLHOFER GMBH
K072916	TRILOGY SYSTEM WITH RAPIDARC	Nov 09, 2007	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K072529	TRACKPORT	Oct 26, 2007	Substantially Equivalent	DIREX SYSTEMS CORP.
K072506	EXACTRAC 5.5	Oct 26, 2007	Substantially Equivalent	BRAINLAB AG
K072046	EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM	Oct 17, 2007	Substantially Equivalent	BRAINLAB AG
K072454	INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS	Oct 16, 2007	Substantially Equivalent	INTEGRA RADIONICS, INC.
K072171	GATECT-RT	Oct 01, 2007	Substantially Equivalent	VISION RT LIMITED
K072504	CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	Sep 21, 2007	Substantially Equivalent	ACCURAY INCORPORATED
K071614	FIDUCIAL MARKERS	Sep 11, 2007	Substantially Equivalent	CIVCO
K072047	MHI-TM2000 LINEAR ACCELERATOR SYSTEM	Aug 29, 2007	Substantially Equivalent	MITSUBISHI HEAVY INDUSTRIES, LTD.
K071531	MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	Aug 22, 2007	Substantially Equivalent	ACCURAY INCORPORATED
K071992	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	Aug 15, 2007	Substantially Equivalent	VARIAN MEDICAL SYSTEMS
K072079	IGUIDE SYSTEM	Aug 14, 2007	Substantially Equivalent	MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA
K071701	TRACKLEAF-10	Jul 23, 2007	Substantially Equivalent	DIREX SYSTEMS CORP.
K071673	ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032	Jul 18, 2007	Substantially Equivalent	ONC SOLUTIONS, INC.
K070611	BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6	Jul 11, 2007	Substantially Equivalent	NOMOS CORP.
K071360	OPTICAL GUIDANCE PLATFORM	Jun 08, 2007	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K070920	FUJI IP CASSETTE TYPE PC	May 22, 2007	Substantially Equivalent	FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K070305	PRE-LOADED VISICOIL	Mar 07, 2007	Substantially Equivalent	RADIOMED CORPORATION
K070094	TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM	Feb 09, 2007	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K063839	POSITIONER	Feb 08, 2007	Substantially Equivalent	C-RAD POSITIONING AB
K063270	RPM RESPIRATORY GATING SYSTEM	Dec 14, 2006	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K063274	ACCULOC BREAST LOCALIZATION SYSTEM	Dec 12, 2006	Substantially Equivalent	NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
K063021	PROFILER 2	Nov 22, 2006	Substantially Equivalent	SUN NUCLEAR CORP.
K062817	PTW DAVID IMRT QC VERIFICATION SYSTEM	Nov 22, 2006	Substantially Equivalent	PTW-NEW YORK CORP.
K062618	TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT	Sep 22, 2006	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K062611	IGUIDE SYSTEM	Sep 20, 2006	Substantially Equivalent	MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA
K060906	CALYPSO 4D LOCALIZATION SYSTEM	Jul 28, 2006	Substantially Equivalent	CALYPSO MEDICAL TECHNOLOGIES INC
K061713	MAGIS1;MAGIS2	Jul 21, 2006	Substantially Equivalent	DIREX SYSTEMS CORP.
K060895	NOMOSSTAT, VERSION 1.0	Jul 21, 2006	Substantially Equivalent	NOMOS CORP.
K061140	TRILOGY RADIOTHERAPY DELIVERY SYSTEM	May 15, 2006	Substantially Equivalent	VARIAN MEDICAL SYSTEMS
K060633	COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0	May 01, 2006	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K060912	MODIFICATION TO: HI-ART SYSTEM	Apr 19, 2006	Substantially Equivalent	TOMOTHERAPY INCORPORATED
K060737	SINMED POSITIONING DEVICES	Mar 31, 2006	Substantially Equivalent	SINMED BV
K060226	ONCOR EXPRESSION	Mar 15, 2006	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K052212	MIGUE	Mar 10, 2006	Substantially Equivalent	DIREX SYSTEMS CORP.
K052705	DART-12	Feb 21, 2006	Substantially Equivalent	DIREX SYSTEMS CORP.
K053500	FRAMELESS RADIOSURGERY COMPONENTS	Feb 03, 2006	Substantially Equivalent	BRAINLAB AG
K052920	DELTA4	Jan 12, 2006	Substantially Equivalent	SCANDIDOS AB
K052682	ALIGNRT	Jan 06, 2006	Substantially Equivalent	VISION RT LIMITED
K052391	VISION (WITH OFF-LINE REVIEW)	Nov 23, 2005	Substantially Equivalent	VARIAN MEDICAL SYSTEMS
K052220	IPLAN RT FIBERTRACKING	Sep 30, 2005	Substantially Equivalent	BRAINLAB AG
K051932	ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5	Aug 12, 2005	Substantially Equivalent	ELEKTA, INC
K051921	THE EDGE DETECTOR, MODEL 1118	Jul 27, 2005	Substantially Equivalent	SUN NUCLEAR CORP.
K042875	NAVIGATOR	Jul 01, 2005	Substantially Equivalent	NOMOS CORP.
K050888	INTEGRA IMMOBILIZATION SYSTEM	May 23, 2005	Substantially Equivalent	DIACOR, INC.
K043409	ACCUCHANGER	May 05, 2005	Substantially Equivalent	DIREX SYSTEMS CORP.
K050701	THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010	Apr 01, 2005	Substantially Equivalent	BIONIX DEVELOPMENT CORP.
K050372	VISITRAK, VERSION 1, RELEASE 1	Mar 25, 2005	Substantially Equivalent	MATH RESOLUTIONS, LLC.
K050479	4D INTEGRATED TREATMENT CONSOLE	Mar 24, 2005	Substantially Equivalent	VARIAN MEDICAL SYSTEMS
K050442	MILLENNIUM MULTI-LEAF COLLIMATOR	Mar 23, 2005	Substantially Equivalent	VARIAN MEDICAL SYSTEMS
K042956	VISION	Mar 11, 2005	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K042794	BEAM MODULATOR, MODEL 4513 332 8000	Jan 31, 2005	Substantially Equivalent	ELEKTA LTD.
K041937	RESTITU	Nov 16, 2004	Substantially Equivalent	RESONANT MEDICAL, INC.
K042720	ON-BOARD IMAGER DEVICE	Oct 29, 2004	Substantially Equivalent	VARIAN MEDICAL SYSTEMS
K041519	MODIFICATION TO: ON-BOARD IMAGER DEVICE	Aug 04, 2004	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K041557	MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W	Jun 25, 2004	Substantially Equivalent	THOMSON & NIELSEN ELECTRONICS, LTD.
K040687	ONEDOSE PATIENT DOSIMETRY SYSTEM	Jun 25, 2004	Substantially Equivalent	SICEL TECHNOLOGIES INC
K041315	CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY	Jun 10, 2004	Substantially Equivalent	ACCURAY, INC.
K040585	EXACTRAC 4.0 AND EXACTRAC X-RAY 6D	May 11, 2004	Substantially Equivalent	BRAINLAB AG
K040709	PROTOS SOFTWARE	Apr 28, 2004	Substantially Equivalent	AKTINA MEDICAL PHYSICS CORP.
K040773	PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM	Apr 09, 2004	Substantially Equivalent	BIONIX DEVELOPMENT CORP.
K034051	DYNATRAC, COD. 50-1A	Apr 05, 2004	Substantially Equivalent	3D LINE USA, INC.
K040192	ON-BOARD IMAGER DEVICE	Feb 27, 2004	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K033343	TRILOGY RADIOTHERAPY DELIVERY SYSTEM	Dec 23, 2003	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K033287	EXACTRAC GATING	Dec 19, 2003	Substantially Equivalent	BRAINLAB AG
K032171	ACCUSOFT	Dec 15, 2003	Substantially Equivalent	DIREX SYSTEMS CORP.
K032762	XIO RADIATION TREATMENT PLANNING SYSTEM	Dec 02, 2003	Substantially Equivalent	COMPUTERIZED MEDICAL SYSTEMS, INC.
K033347	MODIFICATION TO: HI-ART SYSTEM	Nov 12, 2003	Substantially Equivalent	TOMOTHERAPY INCORPORATED
K032996	ELEKTA SYNERGY SYSTEM	Oct 23, 2003	Substantially Equivalent	ELEKTA ONCOLOGY SYSTEMS, LTD.
K032725	MOSFET AUTOSENSE WIRELESS	Oct 03, 2003	Substantially Equivalent	THOMSON & NIELSEN ELECTRONICS, LTD.
K032100	I-BEAM	Oct 02, 2003	Substantially Equivalent	COMPUTERIZED MEDICAL SYSTEMS, INC.
K032248	PRECISE CARBON FIBER TABLE TOP, MODEL 11-999	Sep 25, 2003	Substantially Equivalent	AKTINA MEDICAL PHYSICS CORP.
K032594	ONE DIMENSIONAL WATER PHANTOM, WP 1D	Sep 05, 2003	Substantially Equivalent	WELLHOFER DOSIMETRIE
K031764	ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES	Sep 05, 2003	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K032156	ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT	Sep 02, 2003	Substantially Equivalent	WFR/AQUAPLAST CORP.
K031975	IMSURE	Aug 29, 2003	Substantially Equivalent	PRODIGM, INC.
K031634	OMNIPRO I'MRT	Aug 29, 2003	Substantially Equivalent	WELLHOFER DOSIMETRIE
K031631	STEREOTACTIC BODY FRAME, MODEL COD. 70-1A	Jul 18, 2003	Substantially Equivalent	3D LINE USA, INC.
K030439	HEADFIX	May 08, 2003	Substantially Equivalent	MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
K030175	2 BASIC	Apr 17, 2003	Substantially Equivalent	CAPINTEC, INC.
K030051	VERSABOARD, MODEL 7040	Apr 04, 2003	Substantially Equivalent	BIONIX DEVELOPMENT CORP.
K024284	VICTOREEN THEBES II, MODEL 7020	Mar 11, 2003	Substantially Equivalent	SYNCOR RADIATION MANAGEMENT
K023519	RADIONICS VARILINK 2	Jan 16, 2003	Substantially Equivalent	RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
K023449	NON-INVASIVE PATIENT FIXATION SYSTEM	Jan 13, 2003	Substantially Equivalent	STRYKER LEIBINGER
K021338	ACCULEAF	Jan 07, 2003	Substantially Equivalent	DIREX SYSTEMS CORP.
K023293	MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02	Dec 23, 2002	Substantially Equivalent	MED-TEC,INC.
K023636	BLOCKING TRAY	Nov 22, 2002	Substantially Equivalent	SOUTHEASTERN RADIATION PRODUCTS, INC.
K022708	KLARITY	Nov 12, 2002	Substantially Equivalent	LARSON PRODUCTS, INC.
K020320	RADIOSYSTEM/NT, MODEL 80-13020	Aug 28, 2002	Substantially Equivalent	STYKER INSTRUMENTS
K021124	ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER	Jul 02, 2002	Substantially Equivalent	WFR/AQUAPLAST CORP.
K010065	CRANIAL STEREOTACTIC EQUIPMENT	Jul 02, 2002	Substantially Equivalent	ARPLAY MEDICAL S.A.
K021463	MODEL 1133 IVD PC VERSION	Jun 06, 2002	Substantially Equivalent	SUN NUCLEAR CORP.
K020860	M3 (MICRO-MULTILEAF COLLIMATOR)	Jun 06, 2002	Substantially Equivalent	BRAINLAB AG
K020294	MOTION TRACKING	Apr 22, 2002	Substantially Equivalent	ACCURAY, INC.
K004022	M3 (MIRCO-MULTILEAF COLLIMATOR	Mar 26, 2002	Substantially Equivalent	BRAINLAB AG
K014081	AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES	Mar 05, 2002	Substantially Equivalent	AKTINA MEDICAL PHYSICS CORP.
K014022	MRI LINE MARKER	Mar 04, 2002	Substantially Equivalent	I.Z.I. CORP.
K013391	BODYFIX	Jan 11, 2002	Substantially Equivalent	MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
K011845	MILLCOMP	Dec 04, 2001	Substantially Equivalent	MATH RESOLUTIONS, LLC.
K013279	MOSFET AUTOSENSE, MODEL TN-RD-60	Oct 18, 2001	Substantially Equivalent	THOMSON & NIELSEN ELECTRONICS, LTD.
K012227	MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1	Oct 01, 2001	Substantially Equivalent	ONCOLOGY DATA SYSTEMS, INC.
K004023	INTRA OPERATIVE RADIATION THERAPY	Sep 21, 2001	Substantially Equivalent	ARPLAY MEDICAL S.A.
K011763	OMNIDOS	Sep 05, 2001	Substantially Equivalent	SCANDITRONIX MEDICAL AB
K012289	MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)	Aug 14, 2001	Substantially Equivalent	ELEKTA ONCOLOGY SYSTEMS, LTD.
K011024	CYBERKNIFE SYSTEM	Aug 10, 2001	Substantially Equivalent	ACCURAY, INC.
K003285	EXAC TRAC 2.0 (NOVALIS BODY MODULE)	Jul 31, 2001	Substantially Equivalent	BRAINLAB, AG
K011332	RF-IVD WIRELESS DOSIMETER-MODEL 1133	Jul 26, 2001	Substantially Equivalent	SUN NUCLEAR CORP.
K003779	IMMOBILIZATION SYSTEM FOR ENT	Jul 12, 2001	Substantially Equivalent	ARPLAY MEDICAL S.A.
K010916	PTW DOSIMETRY DIODE, T60008	Jun 20, 2001	Substantially Equivalent	PTW-NEW YORK CORP.
K003778	BREAST-BOARD (MULTIPLE)	Jun 08, 2001	Substantially Equivalent	ARPLAY MEDICAL S.A.
K010464	RADCALC, MODEL V.4.0	May 17, 2001	Substantially Equivalent	LIFELINE SOFTWARE, INC.
K010472	PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50	May 08, 2001	Substantially Equivalent	THOMSON & NIELSEN ELECTRONICS, LTD.
K010449	IVD (IN VIVO DOSIMETER), MODEL 1131	May 04, 2001	Substantially Equivalent	SUN NUCLEAR CORP.
K010975	ECLIPSE 6.5	May 02, 2001	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K010225	DOSIMETRY CHECK	Apr 24, 2001	Substantially Equivalent	MATH RESOLUTIONS, LLC.
K010174	TRAY ADAPTERS, MULTIPLE	Apr 18, 2001	Substantially Equivalent	ARPLAY MEDICAL S.A.
K010063	COUCH FOR TOTAL BODY RADIATION	Apr 02, 2001	Substantially Equivalent	ARPLAY MEDICAL S.A.
K010062	STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM	Mar 13, 2001	Substantially Equivalent	ARPLAY MEDICAL S.A.
K004015	BEAM BLOCK TRAYS	Mar 13, 2001	Substantially Equivalent	ARPLAY MEDICAL S.A.
K003636	PORTALVISION	Feb 02, 2001	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K003330	AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)	Jan 04, 2001	Substantially Equivalent	AKTINA MEDICAL PHYSICS CORP.
K002608	INVAC	Nov 16, 2000	Substantially Equivalent	DUNCAN HYND ASSOCIATES, LTD.
K000246	RADIOCAMERAS EXTRACRANIAL SYSTEM	Oct 20, 2000	Substantially Equivalent	SURGICAL NAVIGATION TECHNOLOGIES, INC.
K002444	PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206	Oct 18, 2000	Substantially Equivalent	SUN NUCLEAR CORP.
K001833	PREFERENCE TREATMENT SYSTEM	Sep 28, 2000	Substantially Equivalent	NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
K002051	INVIDOS	Sep 05, 2000	Substantially Equivalent	SCANDITRONIX MEDICAL AB
K001052	MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX	Aug 30, 2000	Substantially Equivalent	MED-TEC,INC.
K000209	DOSE 1	Aug 18, 2000	Substantially Equivalent	SCANDITRONIX WELLHOFER NORTH AMERICA
K001643	VARIS 1.4G	Jun 23, 2000	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K990209	NOVAC7	Jun 22, 2000	Substantially Equivalent	HITESYS S.P.A.
K991133	MLC FIT	Mar 27, 2000	Substantially Equivalent	IMPAC MEDICAL SYSTEMS, INC.
K994355	RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION	Mar 22, 2000	Substantially Equivalent	SURGICAL NAVIGATION TECHNOLOGIES, INC.
K993960	PERMA-DOC PHANTOM	Feb 14, 2000	Substantially Equivalent	MICK RADIO-NUCLEAR INSTRUMENTS, INC.
K993959	ISOCENTRIC BEAM CHECKER	Feb 14, 2000	Substantially Equivalent	MICK RADIO-NUCLEAR INSTRUMENTS, INC.
K992689	MU PLUS	Feb 10, 2000	Substantially Equivalent	RAD THERAPY SOLUTIONS, INC.
K993742	SUPER TISSUE	Feb 02, 2000	Substantially Equivalent	I.Z.I. CORP.
K993359	RAPTOR TREATMENT PLANNING SYSTEM	Dec 21, 1999	Substantially Equivalent	NOMOS CORP.
K993594	CONFORMAX MMLC VR1	Dec 15, 1999	Substantially Equivalent	RADIONICS, INC.
K993425	PRIMUS	Nov 26, 1999	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K991319	RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS	Sep 21, 1999	Substantially Equivalent	ORFIT INDUSTRIES
K991966	THE NOMOS CHANE II	Sep 03, 1999	Substantially Equivalent	NOMOS CORP.
K991546	AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD	Jul 30, 1999	Substantially Equivalent	AKTINA MEDICAL PHYSICS CORP.
K991523	TLC PEDIATRIC FRAME, MODEL TLC-SYS	Jul 30, 1999	Substantially Equivalent	RADIONICS, INC.
K991336	BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY	Jul 12, 1999	Substantially Equivalent	MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO)
K991107	SHADOW TRAYS	Jun 29, 1999	Substantially Equivalent	MICK RADIO-NUCLEAR INSTRUMENTS, INC.
K990997	AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER	Jun 22, 1999	Substantially Equivalent	AKTINA MEDICAL PHYSICS CORP.
K990833	DOSE CALC, MODEL VS. 1.02	Jun 08, 1999	Substantially Equivalent	INTEGRITY MEDICAL SOFTWARE, INC.
K990734	DPD-12PCC	May 28, 1999	Substantially Equivalent	SCANDITRONIX MEDICAL AB
K984241	ROCS ULTRASEED	May 12, 1999	Substantially Equivalent	RADIATION ONCOLOGY COMPUTER SYSTEMS
K990383	APOLLO 5, APOLLO 10	May 05, 1999	Substantially Equivalent	PRECITRON A.B.
K981535	FOCUS PILOT CONTOURING WORKSTATION	Apr 02, 1999	Substantially Equivalent	COMPUTERIZED MEDICAL SYSTEMS, INC.
K981153	OSIRIS	Mar 17, 1999	Substantially Equivalent	HUESTIS MEDICAL
K990085	MILLENNIUM MLC -120	Feb 08, 1999	Substantially Equivalent	VARIAN ASSOC., INC.
K982549	RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC	Dec 30, 1998	Substantially Equivalent	RADIONICS, INC.
K981911	PROFA	Nov 12, 1998	Substantially Equivalent	DUNCAN HYND ASSOCIATES, LTD.
K982713	RT DESKTOP	Nov 02, 1998	Substantially Equivalent	ELEKTA ONCOLOGY SYSTEMS, LTD.
K982624	MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242	Oct 26, 1998	Substantially Equivalent	MED-TEC,INC.
K981597	RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY	Oct 09, 1998	Substantially Equivalent	RADIONICS, INC.
K982463	EXTRACRANIAL RADIOTHERAPY SYSTEM	Sep 30, 1998	Substantially Equivalent	HOWMEDICA, INC.
K981055	XKNIFE-4	Sep 29, 1998	Substantially Equivalent	RADIONICS, INC.
K981790	IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW	Aug 07, 1998	Substantially Equivalent	ELEKTA ONCOLOGY SYSTEMS, LTD.
K982513	MX MEVATRON	Jul 31, 1998	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K982502	GENESIS IMRT LINEAR ACCELERATOR	Jul 31, 1998	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K981424	NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM	Jul 17, 1998	Substantially Equivalent	NOMOS CORP.
K981346	RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM	Jul 10, 1998	Substantially Equivalent	SURGICAL NAVIGATION TECHNOLOGIES, INC.
K981313	SEQUENCER	Jul 09, 1998	Substantially Equivalent	IMPAC MEDICAL SYSTEMS, INC.
K980904	MUCHECK MONITOR UNIT VALIDATION PROGRAM	Jun 08, 1998	Substantially Equivalent	MEDICAL DOSIMETRY SERVICES, INC.
K980826	EQUIDOSE SOLID STATE DIODE DETECTORS	Jun 01, 1998	Substantially Equivalent	CII MASTEK, INC.
K973936	FOCUS RTP SYSTEM	Jun 01, 1998	Substantially Equivalent	COMPUTERIZED MEDICAL SYSTEMS, INC.
K980750	RADIOCAMERAS PATIENT POSITIONING SYSTEM	May 20, 1998	Substantially Equivalent	SURGICAL NAVIGATION TECHNOLOGIES, INC.
K980379	PROWESS PRO-SIM	May 18, 1998	Substantially Equivalent	SSGI PROWESS SYSTEMS
K980629	VSS, VIRTUAL SIMULATION SYSTEM	May 06, 1998	Substantially Equivalent	NUCLETRON CORP.
K980402	CAPINTEC MODEL 292 ELECTROMETER	Apr 24, 1998	Substantially Equivalent	CAPINTEC, INC.
K974703	CARBON FIBER BREAST BOARD	Mar 10, 1998	Substantially Equivalent	MEDTEC, INC.
K974700	MATRIX MT-MX3	Mar 04, 1998	Substantially Equivalent	MEDTEC, INC.
K974310	NOMOS SLIT COLLIMATOR (BEAK)	Feb 06, 1998	Substantially Equivalent	NOMOS CORP.
K972816	ADVANCED TREATMENT PLANNING SYSTEM	Jan 23, 1998	Substantially Equivalent	ADVANCED RADIATION THERAPY SYSTEMS, INC.
K972451	COREGISTRATION FUNCTION	Jan 22, 1998	Substantially Equivalent	NOMOS CORP.
K973963	120 LEAF MULTILEAF COLLIMATOR	Jan 14, 1998	Substantially Equivalent	MITSUBISHI ELECTRONICS AMERICA, INC.
K973540	ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS	Dec 17, 1997	Substantially Equivalent	ELEKTA ONCOLOGY SYSTEMS, INC.
K973889	VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE	Nov 21, 1997	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K971893	SNT LINAC ACCESSORIES	Nov 13, 1997	Substantially Equivalent	SURGICAL NAVIGATION TECHNOLOGIES, INC.
K972905	XPLAN-1	Oct 28, 1997	Substantially Equivalent	RADIONICS SOFTWARE APPLICATIONS, INC.
K971367	BRAINSCAN CONFORMAL RT MODULE	Oct 27, 1997	Substantially Equivalent	BRAINLAB, AG
K972804	BANG POLYMER GEL DOSIMETER, BANG 533	Oct 23, 1997	Substantially Equivalent	MGS RESEARCH, INC.
K972709	TBI STAND	Oct 16, 1997	Substantially Equivalent	MICK RADIO-NUCLEAR INSTRUMENTS, INC.
K972617	HELAX-VISIR	Oct 01, 1997	Substantially Equivalent	HELAX AB
K972275	LANTIS TREATSTATION	Sep 08, 1997	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K970464	P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1	Sep 05, 1997	Substantially Equivalent	NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
K963451	ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING	Aug 05, 1997	Substantially Equivalent	TOPSLANE
K970384	VELOS CONSTANCY CHECK DEVICE, MODEL 55-145	Jul 29, 1997	Substantially Equivalent	AKTINA MEDICAL PHYSICS CORP.
K965010	TARGET 2 VERSION 1.1	Jul 23, 1997	Substantially Equivalent	GE MEDICAL SYSTEMS
K962950	CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM	Jul 22, 1997	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K970236	THERAPLAN PLUS VERSION 1.2	Jul 09, 1997	Substantially Equivalent	THERATRONICS, INC.
K964206	NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2	Jun 20, 1997	Substantially Equivalent	NUCLETRON CORP.
K964785	VERIDOSE DIODES	Jun 13, 1997	Substantially Equivalent	VICTOREEN, INC.
K971382	PRONE BREAST POSITIONING BOARD, MODEL #37-018	Jun 06, 1997	Substantially Equivalent	VICTOREEN, INC.
K970586	BRAINLAB MICRO MULTI-LEAF COLLIMATOR	May 12, 1997	Substantially Equivalent	BRAINLAB MED. COMPUTERSYSTEME GMBH
K970564	DYNAMIC WEDGE	May 12, 1997	Substantially Equivalent	MITSUBISHI ELECTRONICS AMERICA, INC.
K970291	ACCESSORIES TO THE STEREOTACTIC BODY FRAM	Apr 24, 1997	Substantially Equivalent	ELEKTA INSTRUMENT AB
K970137	EXL-12SP,12DP,15DP,20DP LINAC	Apr 15, 1997	Substantially Equivalent	MITSUBISHI ELECTRONICS AMERICA, INC.
K964517	LINAC SCALPEL FLOORSTAND	Apr 01, 1997	Substantially Equivalent	SURGICAL NAVIGATION TECHNOLOGIES, INC.
K964167	DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY)	Mar 21, 1997	Substantially Equivalent	MULTIDATA SYSTEMS INTERNATIONAL CORP.
K964840	BEAM BLOCK TRAYS	Feb 11, 1997	Substantially Equivalent	AKTINA MEDICAL PHYSICS CORP.
K962335	MLC FIT	Feb 06, 1997	Substantially Equivalent	IMPAC MEDICAL SYSTEMS, INC.
K964485	PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM	Feb 04, 1997	Substantially Equivalent	ELIAV LTD.
K961400	RFA-300, LDA UTILITY	Jan 03, 1997	Substantially Equivalent	SCANDITRONIX MEDICAL AB
K963860	THE NOMOS TALON POSITIONING AND IMMOBILIZATION SYSTEM	Dec 23, 1996	Substantially Equivalent	NOMOS CORP.
K963624	PHILIPS SLI SERIES LINEAR ACCELERATOR	Dec 06, 1996	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K963258	PEACOCK SYSTEM	Nov 18, 1996	Substantially Equivalent	NOMOS CORP.
K962792	LINAC SCALPEL TREATMENT PLANNING SYSTEM	Nov 12, 1996	Substantially Equivalent	SURGICAL NAVIGATION TECHNOLOGIES, INC.
K954679	THERAPLAN PLUS	Nov 08, 1996	Substantially Equivalent	THERATRONICS, INC.
K961484	CASS SYSTEM (MODIFICATION)	Nov 07, 1996	Substantially Equivalent	MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO)
K962487	BREAST TREATMENT AID M200	Sep 09, 1996	Substantially Equivalent	S. AND H. ENGINEERING, INC.
K962080	RPS-50 BEAM SCANNER	Aug 23, 1996	Substantially Equivalent	SOFIELD SCIENCE SERVICES, INC.
K962155	GILL-THOMAS-COSMAN(GTC) DENTAL TRAY	Aug 22, 1996	Substantially Equivalent	RADIONICS SOFTWARE APPLICATIONS, INC.
K961467	HEAD RETAINING DEVICE	Aug 09, 1996	Substantially Equivalent	S. AND H. ENGINEERING, INC.
K961214	MULTI LEAF COLLIMATOR	Aug 06, 1996	Substantially Equivalent	MITSUBISHI INTL. CORP.
K954861	BRAINLAB CT/X-RAY LOCALIZER	Aug 05, 1996	Substantially Equivalent	BRAINLAB MED. COMPUTERSYSTEME GMBH
K960293	MRTOFLM COMPUTER PROGRAM	Aug 01, 1996	Substantially Equivalent	NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
K961170	BREAST TREATMENT AID	Jun 19, 1996	Substantially Equivalent	S. AND H. ENGINEERING, INC.
K961208	0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER	Jun 17, 1996	Substantially Equivalent	PTW-NEW YORK CORP.
K960834	KODAK EC-L CASSETTE	May 28, 1996	Substantially Equivalent	EASTMAN KODAK COMPANY
K960338	STEREOTACTIC BODY FRAME	Apr 23, 1996	Substantially Equivalent	ELEKTA INSTRUMENT AB
K960510	THERAVIEW	Apr 22, 1996	Substantially Equivalent	INFIMED, INC.
K954564	PID-1 PRECISION INTELLIGENT DOSIMETER	Apr 22, 1996	Substantially Equivalent	GAMMEX, INC.
K940663	PEACOCK PLAN	Apr 09, 1996	Substantially Equivalent	NOMOS CORP.
K951581	PINNACLE3 APEX	Apr 08, 1996	Substantially Equivalent	ADAC LABORATORIES
K955774	VARIS PORTALVISION	Mar 15, 1996	Substantially Equivalent	VARIAN ASSOC., INC.
K953508	COMPUTE-RX PLAN PC3D	Feb 26, 1996	Substantially Equivalent	MEDICALIBRATION PHYSICS CONSULTANT SERVICES, INC.
K943224	VARIAN MULTILEAF COLLIMATOR	Feb 02, 1996	Substantially Equivalent	VARIAN ASSOC., INC.
K952314	EXL-12SP & 12DP LINAC	Jan 17, 1996	Substantially Equivalent	MITSUBISHI INTL. CORP.
K954705	ACRYSTEEL BLOCKING TRAY	Jan 05, 1996	Substantially Equivalent	MEDTEC, INC.
K954634	RADIOSURGERY VERIFICATION PHANTOM	Dec 22, 1995	Substantially Equivalent	THE PHANTOM LABORATORY, INC.
K952108	EXL-15DP & 20-DP LINAC	Dec 21, 1995	Substantially Equivalent	MITSUBISHI INTL. CORP.
K946074	ALDERSON BREST DOSIMETRY SYSTEM	Dec 21, 1995	Substantially Equivalent	RADIOLOGY SUPPORT DEVICES, INC.
K954165	PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM	Dec 05, 1995	Substantially Equivalent	PTW-NEW YORK CORP.
K940001	PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)	Nov 14, 1995	Substantially Equivalent	NUCLETRON CORP.
K953570	PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP)	Oct 25, 1995	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K953482	XKNIFE-3	Oct 25, 1995	Substantially Equivalent	RADIONICS SOFTWARE APPLICATIONS, INC.
K951764	UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR	Oct 07, 1995	Substantially Equivalent	PTW-NEW YORK CORP.
K953046	PERI-PUSHER	Sep 22, 1995	Substantially Equivalent	DIACOR, INC.
K952729	PAINTED WEDGE & ROD BREAST BOARD	Sep 15, 1995	Substantially Equivalent	MEDTEC, INC.
K941118	HEAD IMMOBILIZATION APPARATUS	Aug 25, 1995	Substantially Equivalent	NORTHWEST MEDICAL PHYSICS CENTER
K952457	RAPID-FOAM	Aug 23, 1995	Substantially Equivalent	THE SOULE CO., INC.
K950061	HERCULES RADIATION THERAPY COUCH	Aug 16, 1995	Substantially Equivalent	PRECISION THERAPY INTL., INC.
K952189	MED-TEC REDISET	Aug 09, 1995	Substantially Equivalent	MEDTEC, INC.
K944040	PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM	Jul 21, 1995	Substantially Equivalent	S & S X-RAY PRODUCTS, INC.
K950075	MED-TEC TRAY ADAPTER	Jul 13, 1995	Substantially Equivalent	MEDTEC, INC.
K951947	MED-TEC RADIO THERAPY TREATMENT CHAIR	Jul 12, 1995	Substantially Equivalent	MEDTEC, INC.
K951679	MED-TEC TESTICULAR SEPARATOR	Jul 12, 1995	Substantially Equivalent	MEDTEC, INC.
K945321	WELLHOFER WP700 V. 3.2	Jul 12, 1995	Substantially Equivalent	MEDICAL PHYSICS INSTRUMENTATION, INC.
K951808	MED-TEC REDI-FOAM	Jul 06, 1995	Substantially Equivalent	MEDTEC, INC.
K951717	MED-TEC KNEE CRUTCH	Jun 28, 1995	Substantially Equivalent	MEDTEC, INC.
K951143	PULSE KLYSTRON AMPLIFIFER (L-5822-90)	Jun 19, 1995	Substantially Equivalent	LITTON SYSTEMS, INC.
K951142	PULSE KLYSTRON AMPLIFIER (L-5822-00)	Jun 16, 1995	Substantially Equivalent	LITTON SYSTEMS, INC.
K935615	MEDICAL LINEAR ACCELERATOR	Jun 09, 1995	Substantially Equivalent	ACCELERATOR SYSTEMS INTL., INC.
K945903	BRAINLAB MASK SYSTEM	Jun 05, 1995	Substantially Equivalent	BRAINLAB MED. COMPUTERSYSTEME GMBH
K950866	HIP FIXATION SYSTEM	May 30, 1995	Substantially Equivalent	MEDTEC, INC.
K942346	IMAGERT	May 15, 1995	Substantially Equivalent	IMPAC MEDICAL SYSTEMS, INC.
K943714	MICRO MULTILEAF COLLIMATOR	May 12, 1995	Substantially Equivalent	LEIBINGER F.L. FISCHER
K926449	VARIAN MULTILEAF COLLIMATOR, RELEASE 4.0	May 05, 1995	Substantially Equivalent	VARIAN ASSOC., INC.
K933117	IORT SYSTEM	Feb 16, 1995	Substantially Equivalent	NORTHWEST MEDICAL PHYSICS CENTER
K934523	GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1)	Feb 08, 1995	Substantially Equivalent	RADIONICS, INC.
K943464	PHILIPS IMPROVED CHECK RADIOGRAPH OPTION	Feb 01, 1995	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K940145	COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE	Jan 24, 1995	Substantially Equivalent	HUESTIS MACHINE CORP.
K943406	RF DRIVER, RADIO FREQUENCY DRIVER	Dec 15, 1994	Substantially Equivalent	PRO-COMM, INC.
K940660	MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM	Dec 09, 1994	Substantially Equivalent	VICTOREEN, INC.
K943199	MOTORIZED DEPTH DOSE APPARATUS	Dec 07, 1994	Substantially Equivalent	MEDTEC, INC.
K944315	BLOCKING TRAY	Nov 22, 1994	Substantially Equivalent	MEDTEC, INC.
K926008	PINNACLE 3	Oct 04, 1994	Substantially Equivalent	ADAC LABORATORIES
K932501	VARIAN ORIGAMI, VERSION 1.0	Sep 23, 1994	Substantially Equivalent	VARIAN ASSOC., INC.
K930513	VARIAN RMS-2000, RELEASE 2.5	Sep 23, 1994	Substantially Equivalent	VARIAN ASSOC., INC.
K924685	STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM	Sep 16, 1994	Substantially Equivalent	LEIBINGER GMBH
K942083	ADVANCED THERAPY DOSIMETER	Sep 02, 1994	Substantially Equivalent	KEITHLEY INSTRUMENTS, INC.
K930506	THERPAC RADIOTHERAPY TREATMENT PLANNING SYSTEM	Aug 29, 1994	Substantially Equivalent	PINECLIFF ASSOC.
K934303	RFA A-300	Aug 09, 1994	Substantially Equivalent	SCANDITRONIX, INC.
K926321	VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D)	Aug 09, 1994	Substantially Equivalent	VARIAN ASSOC., INC.
K942092	DPD-3	Jul 29, 1994	Substantially Equivalent	SCANDITRONIX, INC.
K935928	RIT 113 FILM ANALYSIS SYSTEM	Jul 29, 1994	Substantially Equivalent	RADIOLOGICAL IMAGING TECHNOLOGY, INC.
K935435	NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST	Jul 29, 1994	Substantially Equivalent	VICTOREEN, INC.
K940237	THERAPLAN V05B/ TP-11 V09B	Jul 26, 1994	Substantially Equivalent	THERATRONICS, INC.
K934657	BRAINLAB LINAC HARDWARE	Jul 22, 1994	Substantially Equivalent	BRAINLAB MED. COMPUTERSYSTEME GMBH
K942282	MED-TEC BREAST SUPPORT SYSTEM	Jul 18, 1994	Substantially Equivalent	MEDTEC, INC.
K935412	MED-TEC, INC. BREAST BOARD, MT-200	Jul 18, 1994	Substantially Equivalent	MEDTEC, INC.
K935411	MED-TEC, INC. BREAST BOARD, MT-250	Jul 18, 1994	Substantially Equivalent	MEDTEC, INC.
K935300	VAC-LOK IMMOBILIZATION SYSTEM	Jul 18, 1994	Substantially Equivalent	MEDTEC, INC.
K933227	UNI-FRAME HEAD IMMOBILIZATION SYSTEM	Jul 18, 1994	Substantially Equivalent	MEDTEC, INC.
K932598	TN-RD-50	Jun 03, 1994	Substantially Equivalent	KEITHLEY INSTRUMENTS, INC.
K935067	AQUAPLAST	May 26, 1994	Substantially Equivalent	WFR/AQUAPLAST CORP.
K922276	THERAC 25	May 25, 1994	Substantially Equivalent	THERATRONICS, INC.
K926187	POSICAST IMMOBILIZATION SYSTEM	Apr 15, 1994	Substantially Equivalent	HUESTIS MACHINE CORP.
K935021	HANDI-FOAM	Apr 07, 1994	Substantially Equivalent	MEDTEC, INC.
K933558	ARM RADIATION BEAM SCANNER	Mar 16, 1994	Substantially Equivalent	ADVANCED RADIATION MEASUREMENTS, INC.
K930182	RADIATION TREATMENT FOR CANCER PATIENTS	Jan 05, 1994	Substantially Equivalent	NORTHWEST MEDICAL PHYSICS CENTER
K931927	VICTOREEN MODEL 530	Nov 15, 1993	Substantially Equivalent	VICTOREEN, INC.
K934566	RADASSIST	Nov 03, 1993	Substantially Equivalent	DIACOR, INC.
K933493	RAM-PACS	Nov 03, 1993	Substantially Equivalent	MEDICAL KNOWLEDGE SYSTEMS, INC.
K933614	PITUITARY BOARD	Oct 07, 1993	Substantially Equivalent	BIONIX DEVELOPMENT CORP.
K933613	3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER	Oct 07, 1993	Substantially Equivalent	BIONIX DEVELOPMENT CORP.
K923522	LINAC-BASED STEROTACTIC RADIOSURGERY	Aug 18, 1993	Substantially Equivalent	RADIONICS SOFTWARE APPLICATIONS, INC.
K930279	REFIX(TM) SYSTEM	Jul 27, 1993	Substantially Equivalent	NOMOS CORP.
K930246	MAMMORX	Jul 26, 1993	Substantially Equivalent	DIACOR, INC.
K925714	BREAST SIMULATION SYSTEM	Jun 08, 1993	Substantially Equivalent	SEVERN RESEARCH, INC.
K924495	PHILIPS RTNET RADIOTHERAPY NETWORKING SYSTEM	Jun 08, 1993	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K924240	PROWESS 2000	May 17, 1993	Substantially Equivalent	SMALL SYSTEMS GROUP, INC.
K924632	LCM-2-LINAC COUCH-MOUNT SYSTEM	Apr 07, 1993	Substantially Equivalent	RADIONICS, INC.
K921740	COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED	Apr 07, 1993	Substantially Equivalent	MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO)
K920879	BRAINSCAN RADIOSURGERY MODULE	Dec 29, 1992	Substantially Equivalent	BRAINLAB
K921991	PLATO RADIATION THERAPY PLANNING SYSTEM	Nov 27, 1992	Substantially Equivalent	NUCLETRON-OLDELFT CORP.
K911973	LINEAR ACCELERATOR COLLIMATOR	Oct 15, 1992	Substantially Equivalent	MEDICAL EQUIPMENT DEVELOPMENT CO., INC.
K914698	SETUP COMPUTER WITH SOFTWARE V-1261,62 AND 63	Jun 05, 1992	Substantially Equivalent	K.S., INC.
K920455	THERAVIEW DIGITAL PORTAL IMAGING COMPUTER (MOD.)	Mar 31, 1992	Substantially Equivalent	S & S INFICON, INC.
K920041	ADAC XL-PLAN-PC	Mar 30, 1992	Substantially Equivalent	ADAC LABORATORIES
K913612	SEQUENCER	Dec 19, 1991	Substantially Equivalent	IMPAC MEDICAL SYSTEMS, INC.
K913674	RECORD AND VERIFY MEVATRON ADAPTER	Nov 22, 1991	Substantially Equivalent	COMPUTERIZED MEDICAL SYSTEMS, INC.
K913119	VARIAN C-SERIES CLINACS (CLINAC 2300C/D)	Nov 07, 1991	Substantially Equivalent	VARIAN ASSOC., INC.
K913174	VARIAN CLINAC 600SR	Nov 05, 1991	Substantially Equivalent	VARIAN ASSOC., INC.
K912630	XKNIFE RADIOSURGERY SYSTEM	Nov 04, 1991	Substantially Equivalent	RSA, INC.
K911750	COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED	Oct 15, 1991	Substantially Equivalent	MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO)
K911612	NUCLETRON PLANNING SYSTEM	Jun 13, 1991	Substantially Equivalent	NUCLETRON-OLDELFT CORP.
K904908	STEREOTACTIC IRRADIATION SYSTEM	Jun 06, 1991	Substantially Equivalent	NORTHWEST MEDICAL PHYSICS CENTER
K901932	VARIAN ELECTRONIC PORTAL IMAGING SYSTEM	May 03, 1991	Substantially Equivalent	VARIAN ASSOC., INC.
K904364	VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C	Feb 27, 1991	Substantially Equivalent	VARIAN ASSOC., INC.
K905007	STANDARD BREAST BOARDS; DELUXE BREAST BOARD	Feb 12, 1991	Substantially Equivalent	BIONIX DEVELOPMENT CORP.
K903139	BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743)	Nov 07, 1990	Substantially Equivalent	SIEMENS MEDICAL LABORATORIES, INC.
K900434	MM-22 MICROTRON, MM50 MICROTRON	Oct 23, 1990	Substantially Equivalent	SCANDITRONIX, INC.
K902339	THERAVIEW DIGITAL PORTAL IMAGING COMPUTER	Aug 23, 1990	Substantially Equivalent	S & S INFICON, INC.
K902849	PHILIPS VERIFLEX	Aug 03, 1990	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K892425	STP COMPLETE MODULE SET	Mar 23, 1990	Substantially Equivalent	LEIBINGER & FISCHER LTD.
K895697	VAC FIX(R) SYSTEM	Jan 12, 1990	Substantially Equivalent	S&S PAR SCIENTIFIC
K894722	RENNER-PLAN	Jan 03, 1990	Substantially Equivalent	W.D. RENNER CONSULTING CO.
K895733	FIBERVISION(TM)	Nov 21, 1989	Substantially Equivalent	FIBER IMAGING, INC.
K895500	PATIENT POSITIONING ACCESSORIES	Nov 06, 1989	Substantially Equivalent	PERKINS MFG. CO.
K894912	SRI 100 RADIOTHERAPY IMAGING SYSTEM	Oct 13, 1989	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K894706	HT-RES RTP SYSTEM	Oct 11, 1989	Substantially Equivalent	ADAC LABORATORIES
K891292	SRS-200 RADIOSURGERY SYSTEM	Sep 18, 1989	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K893978	MEDISYS RECORD AND VERIFY SYSTEM	Sep 01, 1989	Substantially Equivalent	MEDISYS, INC.
K894230	PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735)	Aug 28, 1989	Substantially Equivalent	SIEMENS MEDICAL LABORATORIES, INC.
K894123	VERICORD S3	Aug 28, 1989	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K892845	SOFTWARE RELEASE 1.3 FOR THE SL SERIES LINEAR ACCE	Jul 20, 1989	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K892860	SATURNE 41	Jun 23, 1989	Substantially Equivalent	GENERAL ELECTRIC CO.
K883019	SATURNE 42 AND 43	Nov 10, 1988	Substantially Equivalent	GENERAL ELECTRIC CO.
K883264	SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25	Oct 11, 1988	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K883101	DVS (OPTION 01)	Oct 07, 1988	Substantially Equivalent	O.M.I. ONCOLOGY MICROSYSTEMS, INC.
K883067	MODIFIED SL-SERIES LINEAR ACCELERATORS	Sep 30, 1988	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K882231	SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION)	Sep 22, 1988	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K882729	MEVATRON, M 2 CLASS	Sep 19, 1988	Substantially Equivalent	SIEMENS MEDICAL LABORATORIES, INC.
K882326	VARIAN CLINAC 1800S	Sep 19, 1988	Substantially Equivalent	VARIAN ASSOC., INC.
K880200	EXL-14 MEDICAL LINEAR ACCELERATOR	Aug 04, 1988	Substantially Equivalent	MITSUBISHI INTL. CORP.
K874558	SL SERIES, SL 15, 18, 20 & 25	May 02, 1988	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K873398	EXL-22DP X-RAY RADIATION THERAPY SYSTEM	Apr 29, 1988	Substantially Equivalent	MITSUBISHI INTL. CORP.
K874893	MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR	Feb 17, 1988	Substantially Equivalent	KEITHLEY INSTRUMENTS, INC.
K871214	GRATICULE	May 08, 1987	Substantially Equivalent	MICK RADIO-NUCLEAR INSTRUMENTS, INC.
K870525	PHILIPS MODEL SL75-10 LINEAR ACCELERATOR	Apr 01, 1987	Substantially Equivalent	INDUSTRIAL ACCELERATOR CO.
K864910	MEVACHECK	Mar 16, 1987	Substantially Equivalent	MAGUS MICROCONTROLLERS, INC.
K863705	COMPUTER CONTROLLED EXTENSION (CCX)	Jan 06, 1987	Substantially Equivalent	VARIAN ASSOC., INC.
K862339	MEVATRON KD-2	Oct 29, 1986	Substantially Equivalent	SIEMENS MEDICAL LABORATORIES, INC.
K862645	CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C)	Oct 03, 1986	Substantially Equivalent	VARIAN ASSOC., INC.
K863358	VARIAN RMS-2000	Sep 19, 1986	Substantially Equivalent	VARIAN ASSOC., INC.
K862065	PC-PLAN	Aug 26, 1986	Substantially Equivalent	DOSIMETRIX, INC.
K852609	MEVASSIST(SETUP CONTROLLER)	Feb 06, 1986	Substantially Equivalent	MAGUS MICROCONTROLLERS, INC.
K851041	ADAC MODELS XL-PLAN 23 & XL-PLAN 73	Jul 18, 1985	Substantially Equivalent	ADAC LABORATORIES
K840136	LINEAR ACCELERATOR MULTIPLE EXL 3-4-6	Mar 16, 1984	Substantially Equivalent	ADAC LABORATORIES
K833941	ORION	Dec 29, 1983	Substantially Equivalent	CGR MEDICAL CORP.
K832732	RADIOTHERAPY MGMT. SYSTEM RMS-1000	Sep 29, 1983	Substantially Equivalent	VARIAN ASSOC., INC.
K832503	CLINAC 1800	Sep 12, 1983	Substantially Equivalent	VARIAN ASSOC., INC.
K832502	ELECTRON BEAM OPTION FOR CLINAC 15 MEV	Sep 12, 1983	Substantially Equivalent	VARIAN ASSOC., INC.
K832216	VARIAN CLINACOMP 100 TISSUE COMPENSATOR	Sep 12, 1983	Substantially Equivalent	VARIAN ASSOC., INC.
K837347	LINEAR ACCELERATOR THERAC 25	Jun 24, 1983	Substantially Equivalent	ATOMIC ENERGY OF CANADA
K820448	ARS-1000	Mar 31, 1982	Substantially Equivalent	APPLIED RADIATION
K820310	DELTA PLAN II RADIATION THERAPY PLAN	Mar 31, 1982	Substantially Equivalent	TECHNICARE CORP.
K812032	MEVATRON 67E	Aug 18, 1981	Substantially Equivalent	SIEMENS MEDICAL LABORATORIES, INC.
K802809	ELECTRON ARC THERAPY	Jan 07, 1981	Substantially Equivalent	VARIAN ASSOC., INC.
K802808	6MV PORT FILM CAPABILITY OPTION	Jan 07, 1981	Substantially Equivalent	VARIAN ASSOC., INC.
K800792	ADJUSTABLE HEAD & FACE HOLDER	May 14, 1980	Substantially Equivalent	RADIATION PRODUCTS DESIGN, INC.
K800791	MYLAR WINDOW-TABLE INSERT PANEL	May 14, 1980	Substantially Equivalent	RADIATION PRODUCTS DESIGN, INC.
K800790	TENNIS RACKET-TABLE INSERT PANEL	May 14, 1980	Substantially Equivalent	RADIATION PRODUCTS DESIGN, INC.
K800761	POINT TO POINT LEVEL	May 14, 1980	Substantially Equivalent	RADIATION PRODUCTS DESIGN, INC.
K800759	ELEV. BACK SUPPORT W/ADJ. ARM POSITIONER	May 14, 1980	Substantially Equivalent	RADIATION PRODUCTS DESIGN, INC.
K791967	MEVATRON 74X MEDICAL LINEAR ACCELERATOR	Nov 16, 1979	Substantially Equivalent	SIEMENS MEDICAL LABORATORIES, INC.
K790747	MEVATRON 74	May 04, 1979	Substantially Equivalent	SIEMENS MEDICAL LABORATORIES, INC.
K790688	MEVATRON 67	Apr 23, 1979	Substantially Equivalent	SIEMENS MEDICAL LABORATORIES, INC.
K790388	MEVATRON 60	Mar 26, 1979	Substantially Equivalent	SIEMENS MEDICAL LABORATORIES, INC.
K781872	CLINAC 2500	Nov 27, 1978	Substantially Equivalent	VARIAN ASSOC., INC.
K781174	CLINAC 12/10	Sep 14, 1978	Substantially Equivalent	VARIAN ASSOC., INC.
K781057	CLINAC 20 (OPTIONAL 18 MV VERSION)	Jul 17, 1978	Substantially Equivalent	VARIAN ASSOC., INC.
K780027	ACCELERATOR, LINEAR, MED.	Jan 26, 1978	Substantially Equivalent	EMI THERAPY SYSTEMS, INC.
K771902	EMI FOUR	Oct 19, 1977	Substantially Equivalent	EMI THERAPY SYSTEMS, INC.
K771809	CLINAC 6/100	Oct 19, 1977	Substantially Equivalent	VARIAN ASSOC., INC.
K771808	CLINAC 4/100	Oct 19, 1977	Substantially Equivalent	VARIAN ASSOC., INC.
K771358	CLINAC 20	Aug 16, 1977	Substantially Equivalent	VARIAN ASSOC., INC.
K771260	LINEAR ACCELERATOR G-2900	Aug 03, 1977	Substantially Equivalent	ATOMIC ENERGY OF CANADA

FEI Numbers

This FDA classification entry is associated with 123 FEI numbers. Click on an entry to view related FDA registrations.

1000113153: 3 registrations

1000115748: 14 registrations

1000123143: 29 registrations

1000143606: 30 registrations

1000160359: 1 registration

1000162206: 17 registrations

1000208827: 16 registrations

1000227792: 29 registrations

1000306139: 80 registrations

1000518731: 132 registrations

1000521490: 18 registrations

1000523114: 64 registrations

1038814: 23 registrations

1047843: 371 registrations

1219183: 15 registrations

1220477: 911 registrations

1450662: 954 registrations

1526854: 18 registrations

1720929: 257 registrations

1721113: 4 registrations

2155: 5 registrations

2182762: 22 registrations

2183744: 663 registrations

2431392: 29 registrations

2434141: 33 registrations

2916710: 35 registrations

2921581: 14 registrations

2939248: 11 registrations

3000253133: 5 registrations

3001236129: 9 registrations

3001722928: 110 registrations

3002619595: 88 registrations

3002619738: 16 registrations

3002802883: 1 registration

3002806900: 3 registrations

3002807314: 432 registrations

3002807880: 255 registrations

3002808157: 141 registrations

3002913962: 53 registrations

3003062786: 3 registrations

3003094912: 23 registrations

3003251135: 6 registrations

3003418325: 774 registrations

3003477135: 383 registrations

3003586672: 13 registrations

3003793371: 9 registrations

3003803149: 8 registrations

3003873069: 14 registrations

3004363352: 22 registrations

3004580128: 4 registrations

3004594159: 3 registrations

3004608878: 226 registrations

3004637983: 1 registration

3004753785: 10 registrations

3004832819: 9 registrations

3004962788: 18 registrations

3005099803: 218 registrations

3005596716: 4 registrations

3006073271: 3 registrations

3006405073: 49 registrations

3006621300: 5 registrations

3006630150: 15 registrations

3006653576: 17 registrations

3006894636: 20 registrations

3006946288: 14 registrations

3006981798: 57 registrations

3007037519: 4 registrations

3007165183: 1 registration

3007350713: 40 registrations

3007360740: 13 registrations

3007546534: 1 registration

3007615597: 6 registrations

3007791541: 3 registrations

3008191247: 4 registrations

3008317830: 6 registrations

3008706707: 3 registrations

3009039068: 63 registrations

3009077524: 178 registrations

3009140718: 2 registrations

3009302839: 6 registrations

3009394603: 1 registration

3009607881: 4 registrations

3009649442: 9 registrations

3009754495: 2 registrations

3009773332: 4 registrations

3009894282: 1 registration

3010123525: 7 registrations

3010625741: 4 registrations

3010701021: 5 registrations

3010875109: 1 registration

3011716550: 2 registrations

3012039133: 1 registration

3012205931: 4 registrations

3012631246: 4 registrations

3013012623: 6 registrations

3013410552: 12 registrations

3014113695: 1 registration

3014404697: 1 registration

3014428919: 7 registrations

3015119628: 1 registration

3015196842: 1 registration

3015232217: 97 registrations

3015276088: 90 registrations

3015496236: 1 registration

3015534535: 1 registration

3015548663: 16 registrations

3015620182: 3 registrations

3015621321: 4 registrations

3016591365: 1 registration

3016602874: 59 registrations

3016686005: 4 registrations

3018004899: 8 registrations

3018094310: 1198 registrations

3019552217: 2 registrations

3022719374: 2 registrations

3023200024: 5 registrations

3025765259: 3 registrations

3026961165: 1 registration

3027080417: 1 registration

3030077501: 1 registration

3030254046: 1 registration

3031194398: 2 registrations

3038289344: 1 registration