Product Code: KPQ FDA class 2 21 CFR 892.5840

System, Simulation, Radiation Therapy

Radiology

This device is a radiation therapy simulation system used to plan and verify the delivery of radiation treatment, enabling clinicians to define target volumes and confirm beam positioning before actual therapy sessions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPQ, regulated under 21 CFR 892.5840 within the Radiology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: KPQ
Device Class: FDA class 2
Regulation Number: 892.5840
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 70 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K132944	ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION	Mar 14, 2014	Substantially Equivalent	Ge Hungary Kft
K132045	ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS	Sep 04, 2013	Substantially Equivalent	Ge Hungary Kft
K101038	RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER	Aug 17, 2010	Substantially Equivalent	Acceletronics Digital Imaging, LLC
K090706	ONCENTRA SIMULATION 2.3	Jun 15, 2009	Substantially Equivalent	Nucletron Corporation
K083591	IKOENGELO, VERSION 2	Dec 29, 2008	Substantially Equivalent	Ikoetech, LLC
K072445	INTEGRATED BRACHYTHERAPY UNIT - DIGITAL	Sep 14, 2007	Substantially Equivalent	Nucletron Corp.
K061006	IKOENGELO	Jun 05, 2006	Substantially Equivalent	Ikoetech, LLC
K052361	SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM	Oct 24, 2005	Substantially Equivalent	Nucletron Corporation
K052345	ADVANTAGE SIM MD	Sep 14, 2005	Substantially Equivalent	GE Healthcare
K033470	SIMULIX EVOLUTION	Feb 04, 2004	Substantially Equivalent	Nucletron Corporation
K033339	ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY	Dec 30, 2003	Substantially Equivalent	Varian Medical Systems, Inc.
K032550	EXOMIO, MODEL 2.0 SP1	Sep 25, 2003	Substantially Equivalent	Medcom GmbH
K023052	ACUITY RADIATION THERAPY SIMULATOR	Oct 11, 2002	Substantially Equivalent	Varian Medical Systems, Inc.
K022219	EXOMIO, MODEL 1.1	Oct 07, 2002	Substantially Equivalent	Medcom GmbH
K021780	ADVANTAGE SIM 6.0	Jul 29, 2002	Substantially Equivalent	General Electric Medical Systems
K013531	QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00	Nov 07, 2001	Substantially Equivalent	Impac Medical Systems, Inc.
K992751	SOMAVISION	Feb 16, 2000	Substantially Equivalent	Varian Assoc., Inc.
K982857	HELAX-IMCON, VERSION 1.0	Nov 04, 1998	Substantially Equivalent	Helax AB
K973848	IBU, INTEGRATED BRACHY THERAPY UNIT	Jan 22, 1998	Substantially Equivalent	Nucletron Corp.
K971839	VARIAN RADIATION THERAPY IMAGING SYSTEM	Aug 15, 1997	Substantially Equivalent	Varian Medical Systems, Inc.
K964972	SHADOWFORM	May 05, 1997	Substantially Equivalent	I.Z.I. Medical Products Corp.
K964138	VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE	Jan 10, 1997	Substantially Equivalent	Varian Medical Systems, Inc.
K953233	SIMVIEW 3000 CT OPTION	Nov 29, 1996	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K960737	MODEL 555 010 XY CONVERSION(55010)	May 22, 1996	Substantially Equivalent	Systems Supply Services, Inc.
K951830	ADVANTAGE SIM	Nov 13, 1995	Substantially Equivalent	General Electric Co.
K945838	CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY	Oct 25, 1995	Substantially Equivalent	Toshiba America Medical Systems, In.C
K946128	SIMULIX-HP	May 12, 1995	Substantially Equivalent	Oldelft Corp. of America
K946053	SIMVIEW(TM) 3000	Mar 31, 1995	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K930213	MODEL ASYM-100	Sep 07, 1993	Substantially Equivalent	Nucletron Mfg. Corp.
K921108	CMS RECORD AND VERIFY	Nov 02, 1992	Substantially Equivalent	Computerized Medical Systems, Inc.
K923851	ACQSIM SIMULATOR/LOCALIZER	Oct 27, 1992	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K922287	E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS	Oct 16, 1992	Substantially Equivalent	I.Z.I. Corp.
K920506	CONTOURING DEVICE	Oct 14, 1992	Substantially Equivalent	X-Icon Medical Systems
K921876	MKS BEAM OUTLINE PROJECTOR	Jun 25, 1992	Substantially Equivalent	Medical Knowledge Systems, Inc.
K914926	SCANDIPLAN - VERSION 338	May 28, 1992	Substantially Equivalent	Scanditronix, Inc.
K913017	MODULEX RTP SYSTEM	Oct 17, 1991	Substantially Equivalent	Computerized Medical Systems, Inc.
K903313	RAHD 3100	Oct 07, 1991	Substantially Equivalent	Esm , Ltd.
K910647	XIMATRON/CT OPTION	Sep 19, 1991	Substantially Equivalent	Fischer Imaging Corp.
K911340	AUTOCOMP	Aug 26, 1991	Substantially Equivalent	Victoreen, Inc.
K912466	OLDELFT SIMULIX-MC	Jun 28, 1991	Substantially Equivalent	Oldelft Corp. of America
K910367	COMPUTE-RX-COMP (TM)	May 30, 1991	Substantially Equivalent	Medicalibration Physics Consultant Services, Inc.
K896555	CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT	Apr 26, 1990	Substantially Equivalent	W. L. Systems, Inc.
K894568	NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM	Jan 09, 1990	Substantially Equivalent	Advanced Medical Systems, Inc.
K896353	GE TARGET SERIES 2	Dec 22, 1989	Substantially Equivalent	GE Medical Systems
K895442	THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL	Dec 14, 1989	Substantially Equivalent	Altek Corp.
K884261	PROWESS 2000	Aug 04, 1989	Substantially Equivalent	Small Systems Group, Inc.
K891293	SLS SIMULATOR (MODELS SLS-9 AND SLS-14)	Apr 20, 1989	Substantially Equivalent	Philips Medical Systems North America, Inc.
K884323	XIMAVIEW(TM)	Apr 03, 1989	Substantially Equivalent	Varian Assoc., Inc.
K885081	SIMRITE VERIFICATION AND SIMULATION SYSTEM	Mar 22, 1989	Substantially Equivalent	Haynes Radiation Ltd., Inc.
K873580	MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR	Nov 02, 1987	Substantially Equivalent	Medical High Technology International, Inc.
K870221	T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING)	May 12, 1987	Substantially Equivalent	Kermath Mfg. Corp.
K854880	RADIATION BEAM DATA ACQUISTIOIN SYSTEMS	Jan 10, 1986	Substantially Equivalent	Computerized Medical Systems, Inc.
K853671	BEAMSCAN	Jan 10, 1986	Substantially Equivalent	Victoreen, Inc.
K853349	VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST	Oct 28, 1985	Substantially Equivalent	Varian Assoc., Inc.
K852410	MEVAPLAN AND SOMADOS	Oct 28, 1985	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K851813	THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE	Aug 07, 1985	Substantially Equivalent	Victoreen, Inc.
K850977	COMPUTE RX-PLAN	Jul 26, 1985	Substantially Equivalent	Medicalibration
K851653	VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP	May 23, 1985	Substantially Equivalent	Varian Assoc., Inc.
K834281	RAD II SIMULATOR	Dec 29, 1983	Substantially Equivalent	Haynes Radiation Ltd., Inc.
K812726	KERMATH THERAPY SIMULATOR	Nov 05, 1981	Substantially Equivalent	Kermath Mfg. Corp.
K810858	XIMATRON V	May 13, 1981	Substantially Equivalent	Siemens Corp.
K803124	SIDOS U.	Jan 22, 1981	Substantially Equivalent	Siemens Corp.
K803032	PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL.	Jan 22, 1981	Substantially Equivalent	Pfizer Medical Systems, Inc.
K782005	RADIATION ONCOLOGY SYSTEM	Dec 20, 1978	Substantially Equivalent	Adac Laboratories
K781519	EMI SIMULATOR REMOTE CONTROL CONSOLE	Sep 14, 1978	Substantially Equivalent	Emi Medical, Inc.
K781496	XIMATRON IV	Sep 14, 1978	Substantially Equivalent	Siemens Elema AB
K780963	X-RAY SYSTEM	Jun 27, 1978	Substantially Equivalent	General X-Ray, Inc.
K770202	CTM (CLINAC TREATMENT MONITOR)	Feb 07, 1977	Substantially Equivalent	Varian Assoc., Inc.
K761265	VARIPLAN COMPUT. RADIOTHERAPY	Dec 21, 1976	Substantially Equivalent	Varian Assoc., Inc.
K760420	FILTER, VACUUM LINE LINEGUARD	Aug 23, 1976	Substantially Equivalent	Diemolding Corp.