Product Code: IZI FDA class 2 21 CFR 892.1600

System, X-Ray, Angiographic

Radiology

An angiographic X-ray system is used to visualize blood vessels and cardiac structures by imaging the passage of contrast medium through the vascular system, supporting diagnosis and interventional procedures in cardiology and radiology. It is classified as FDA Class 2, reflecting moderate risk and a 510(k) premarket clearance requirement. The product code is IZI, regulated under 21 CFR 892.1600, within the Radiology medical specialty. No special flags apply to this device.

View on FDA

510(k)s

199

FEI Numbers

123

Registration Numbers

123

Unique Applicants

Years Active

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Basic Information

Product Code: IZI
Device Class: FDA class 2
Regulation Number: 892.1600
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 199 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261037	780 nm SPY Portable Handheld Imaging (SPY-PHI) System	May 28, 2026	Substantially Equivalent	Stryker Endoscopy
K253181	SURGIMAGE SIM 1000H Fluorescence Imaging Platform	May 13, 2026	Substantially Equivalent	Surgimage Corporation
K243645	IC-Flow Imaging System 2.0	Sep 22, 2025	Substantially Equivalent	Diagnostic Green GmbH
K243077	Affirm 800	Jun 27, 2025	Substantially Equivalent	Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
K231986	Modus IR	Mar 25, 2024	Substantially Equivalent	Synaptive Medical, Inc.
K234090	EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)	Mar 20, 2024	Substantially Equivalent	Surgvision GmbH
K231075	Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)	Jun 20, 2023	Substantially Equivalent	Carl Zeiss Meditec, Inc.
K230727	SPY Portable Handheld Imaging (SPY-PHI) System	Jun 05, 2023	Substantially Equivalent	Novadaq Technologies Ulc (A Part of Stryker)
K222240	EXPLORER AIR® II	Feb 28, 2023	Substantially Equivalent	Surgvision GmbH
K214097	Explorer Air II	Feb 25, 2022	Substantially Equivalent	Surgvision GmbH
K202391	DIR 800	Jan 21, 2021	Substantially Equivalent	Aesculap, Inc.
K192761	Asimov-MKS Imaging System	Jan 17, 2020	Substantially Equivalent	Onlume, Inc.
K190772	SURGICAL MICROSCOPE SYSTEM ORBEYE with IR	Oct 10, 2019	Substantially Equivalent	Olympus Medical Systems Corp.
K182907	SPY Elite Intraoperative Perfusion Assessment System	Jan 23, 2019	Substantially Equivalent	Novadaq Technologies Ulc. (Now A Part of Stryker)
K181537	GLOW800	Sep 07, 2018	Substantially Equivalent	Leica Microsystems (Schweiz) AG
K180019	CAAS Workstation	May 03, 2018	Substantially Equivalent	Pie Medical Imaging BV
K162991	YELLOW 560 Fluorescence Module	Jul 24, 2017	Unknown	Carl Zeiss Meditec, AG
K170239	Leica FL560	Jul 05, 2017	Unknown	Leica Microsystems (Schweiz) AG
K151780	CAAS Workstation	Mar 11, 2016	Substantially Equivalent	Pie Medical Imaging BV
K141136	LEICA FL800	Aug 19, 2014	Substantially Equivalent	Leica Biosystems Richmond
K133719	PDE-NEO	Mar 27, 2014	Substantially Equivalent	Hamamatsu Photonics K.K.
K133993	CAAS WORKSTATION	Mar 25, 2014	Substantially Equivalent	Pie Medical Imaging
K130003	XIRALITE FLOURESCENCE IMAGING SYSTEM X4	Jan 31, 2014	Substantially Equivalent	Mivenion GmbH
K130842	ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES	May 21, 2013	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K113594	C-THV SYSTEM	Mar 02, 2012	Substantially Equivalent	Paieon, Inc.
K113034	GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM	Dec 13, 2011	Substantially Equivalent	GE Healthcare
K111209	INTEGRATED INNOVA - S5I SYSTEM OPTION	Jul 26, 2011	Substantially Equivalent	GE Healthcare
K110256	THE IC-PRO SYSTEM	May 27, 2011	Substantially Equivalent	Paieon, Inc.
K100371	SPY INTRA-OPERATIVE IMAGING SYSTEM	Feb 04, 2011	Substantially Equivalent	Novadaq Technologies, Inc.
K100849	SYNC-RX SYSTEM, MODEL AS00010	May 21, 2010	Substantially Equivalent	Sync-Rx, Ltd.
K100468	ZEISS INFRARED 800 WITH FLOW 800 OPTION	Mar 03, 2010	Substantially Equivalent	Carl Zeiss Surgical GmbH
K090745	ARTIS ZEE / ZEEGOS WITH SW VC14	Jun 18, 2009	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K083745	THE IC-PRO SYSTEM, MODEL VERSION 3.2	Feb 17, 2009	Substantially Equivalent	Paieon, Inc.
K082907	IC-PRO SYSTEM, VERSION 3.1.0.4	Nov 18, 2008	Substantially Equivalent	Paieon, Inc.
K073328	CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA	Sep 09, 2008	Substantially Equivalent	Paieon, Inc.
K080612	LEICA FL800	May 09, 2008	Substantially Equivalent	Leica Microsystems (Schweiz) AG
K073290	ARTIS ZEE AND ZEEGO	Feb 11, 2008	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K073130	SPY FLUORESCENT IMAGING SYSTEM	Jan 10, 2008	Substantially Equivalent	Novadaq Technologies, Inc.
K073088	SPY FLUORESCENT IMAGING SYSTEM	Jan 10, 2008	Substantially Equivalent	Novadaq Technologies, Inc.
K071619	SPY FLUORESCENT IMAGING SYSTEM	Nov 09, 2007	Substantially Equivalent	Novadaq Technologies, Inc.
K072591	CARDIOP-B SYSTEM, VERSION 2.1	Oct 10, 2007	Substantially Equivalent	Paieon, Inc.
K072222	SPY FLUORESCENT IMAGING SYSTEM	Sep 07, 2007	Substantially Equivalent	Novadaq Technologies, Inc.
K072006	DAR-9400F	Aug 31, 2007	Substantially Equivalent	Shimadzu Corp.
K071717	GE OEC ALTITUDE	Jul 05, 2007	Substantially Equivalent	Shimadzu Corp.
K071037	SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000	May 10, 2007	Substantially Equivalent	Novadaq Technologies, Inc.
K063345	SPY IMAGING SYSTEM	Jan 12, 2007	Substantially Equivalent	Novadaq Technologies, Inc.
K062360	BRANSIST SAFIRE	Oct 05, 2006	Substantially Equivalent	Shimadzu Corp.
K061871	LEICA MODEL FL800	Sep 20, 2006	Substantially Equivalent	Leica Microsystems, Inc.
K060867	SPY INTRAOPERATIVE IMAGING SYSTEM	May 03, 2006	Substantially Equivalent	Novadaq Technologies, Inc.
K060749	XPERCT	Apr 04, 2006	Substantially Equivalent	Philips Medical Systems North America Co.
K052500	DAR-8000F	Oct 17, 2005	Substantially Equivalent	Shimadzu Medical Systems
K052076	DAR-8000I	Sep 02, 2005	Substantially Equivalent	Shimadzu Medical Systems
K052039	GE OEC ALTITUDE	Aug 11, 2005	Substantially Equivalent	Ge Oec Medical Systems
K042961	SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000	Jan 19, 2005	Substantially Equivalent	Novadaq Technologies, Inc.
K042646	DYNACT	Oct 19, 2004	Substantially Equivalent	Siemens Medical Systems, Inc.
K041949	ALLURA XPER FD10	Jul 30, 2004	Substantially Equivalent	Philips Medical Systems North America Co.
K041027	DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D	May 14, 2004	Substantially Equivalent	Toshibamedical Systems Corporation
K030139	THE CARDIOP-B SYSTEM	Apr 02, 2004	Substantially Equivalent	Paieon, Inc.
K032443	DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE	Feb 20, 2004	Substantially Equivalent	Shimadzu Corp.
K033184	LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400	Dec 09, 2003	Substantially Equivalent	Shimadzu Corp.
K031333	PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2	May 13, 2003	Substantially Equivalent	Philips Medical Systems North America, Inc.
K023970	QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS	Jan 24, 2003	Substantially Equivalent	Medis Medical Imaging Systems BV
K023441	PHILIPS MULTIDIAGNOST ELEVA	Oct 30, 2002	Substantially Equivalent	Philips Medical Systems
K010721	AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM	Mar 30, 2001	Substantially Equivalent	Siemens Medical Corp.
K010391	ATLAS MULTI-PURPOSE DSA SYSTEM	Mar 12, 2001	Substantially Equivalent	Cares Built, Inc.
K002840	MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM	Nov 17, 2000	Substantially Equivalent	The Phantom Laboratory, Inc.
K993947	KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY	Dec 21, 1999	Substantially Equivalent	Siemens Corp.
K993765	QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)	Nov 26, 1999	Substantially Equivalent	Medis Medical Imaging Systems BV
K993763	QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)	Nov 26, 1999	Substantially Equivalent	Medis Medical Imaging Systems BV
K991922	DIGITAL IMAGING SYSTEM (BSR)	Sep 01, 1999	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K991231	HITACHI VERSIFLEX	May 24, 1999	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K984545	RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS	Feb 25, 1999	Substantially Equivalent	Philips Medical Systems North America, Inc.
K983877	PHILIPS INTEGRIS 3D RA OPTION	Dec 21, 1998	Substantially Equivalent	Philips Medical Systems North America, Inc.
K982203	CAAS II LVA BIPLANE OPTION	Jul 14, 1998	Substantially Equivalent	Pie Medical Equipment B.V.
K974679	THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM	Mar 23, 1998	Substantially Equivalent	Medcon , Ltd.
K974367	ADVANTX LCN, ADVANTX LCLP	Feb 13, 1998	Substantially Equivalent	GE Medical Systems
K973270	LEG'MAP OPTION	Nov 25, 1997	Substantially Equivalent	Ge Medical Systems, Inc.
K973482	PHILIPS INTEGRIS V5000 AND BV5000	Nov 10, 1997	Substantially Equivalent	Philips Medical Systems North America, Inc.
K972655	CONTROL SYRINGE	Nov 04, 1997	Substantially Equivalent	Medical Specialties Intl., Inc.
K973368	STRAIT'MAP OPTION	Oct 17, 1997	Substantially Equivalent	Ge Medical Systems, Inc.
K972229	IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM	Oct 16, 1997	Substantially Equivalent	Heartware, Inc.
K973342	DAR-3000B	Oct 08, 1997	Substantially Equivalent	Shimadzu Corp.
K971176	VIEW ARCHIVING STATION	Sep 03, 1997	Substantially Equivalent	Electromed Intl., Ltd.
K971181	THE MIDVIEW-MEDCON'S DICOM VIEWER	Jul 29, 1997	Substantially Equivalent	Medcon , Ltd.
K971489	RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4	Jul 03, 1997	Substantially Equivalent	Philips Medical Systems North America, Inc.
K972136	TV MONITOR (P12/17)	Jun 26, 1997	Substantially Equivalent	Perkins Mfg. Co.
K971365	PHILIPS INTEGRIS H5000	May 14, 1997	Substantially Equivalent	Philips Medical Systems North America, Inc.
K970738	KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT	May 07, 1997	Substantially Equivalent	Jamieson Film Co.
K970525	STATNET	Apr 16, 1997	Substantially Equivalent	Gorca Systems, Inc.
K955179	CONTRAST MEDIA SET	Mar 12, 1997	Substantially Equivalent	B.Braun Medical, Inc.
K961451	DICOMNET	Jul 03, 1996	Substantially Equivalent	Lockheed Martin Communications Systems
K955519	ANALYTICAL REVIEW STATION	May 09, 1996	Substantially Equivalent	Camtronics, Ltd.
K960575	ADVANTX LCV+	May 07, 1996	Substantially Equivalent	GE Medical Systems
K954581	ARC SERIES	Dec 21, 1995	Substantially Equivalent	Continental X-Ray Corp.
K955395	DAR-2400-15B/30B	Dec 11, 1995	Substantially Equivalent	Shimadzu Medical Systems
K945400	HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100	Nov 20, 1995	Substantially Equivalent	Hitachi Medical Corp. of America
K954309	ANGIOREX	Oct 06, 1995	Substantially Equivalent	Toshiba Medical Systems
K953563	VANGUARD XR-350 CINEANGIOGRAM PROJECTOR	Oct 05, 1995	Substantially Equivalent	Jamieson Film Co.
K952704	PHILIPS EASYVISION	Jul 03, 1995	Substantially Equivalent	Philips Medical Systems, Inc.
K945540	CAAS II	Jun 28, 1995	Substantially Equivalent	Pie Medical Equipment B.V.
K946378	BCM 400CP	May 04, 1995	Substantially Equivalent	B C Medical , Ltd.
K945449	UNICATH LLU ANGIOGRAPHIC SYSTEM	Feb 27, 1995	Substantially Equivalent	Xre Corp.
K944952	ANGIOGRAPHIC SYSTEM	Feb 17, 1995	Substantially Equivalent	Acoma Medical Imaging, Inc.
K943545	CEILING SUSPENDED C-ARM SUPPORT MH-100	Feb 03, 1995	Substantially Equivalent	Shimadzu Medical Systems
K945459	DLX	Jan 30, 1995	Substantially Equivalent	General Electric Co.
K945375	ADVANTX LCA	Jan 30, 1995	Substantially Equivalent	GE Medical Systems
K945293	TOP ACOM STATION	Jan 05, 1995	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K945483	COMPAS	Dec 09, 1994	Substantially Equivalent	General Electric Co.
K943355	GEMNET	Nov 07, 1994	Substantially Equivalent	GE Medical Systems
K940172	CARDIOVASCULAR MEASUREMENT SYSTEM-CMS	Sep 29, 1994	Substantially Equivalent	Medis Medical Imaging Systems, Inc.
K936002	CINEMAC QAS	Sep 09, 1994	Substantially Equivalent	Xre Corp.
K935026	DIGITAL MEDIA CONVERTER (D-MC)	Aug 24, 1994	Substantially Equivalent	Eigen Video
K941979	VIDEO PLUS WITH ANALYTICAL WORKSTATION	Aug 17, 1994	Substantially Equivalent	Camtronics, Ltd.
K942503	UNICATH FAMILY	Jul 20, 1994	Substantially Equivalent	Angiographic Devices Corp.
K942120	ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION	Jul 18, 1994	Substantially Equivalent	GE Medical Systems
K941177	ANGIOREX CAS-05A	Jun 06, 1994	Substantially Equivalent	Toshiba America Medical Systems, In.C
K941946	LCA ANGIOGRAPHIC IMAGING SYSTEM	May 20, 1994	Substantially Equivalent	GE Medical Systems
K940484	COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM	Apr 19, 1994	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K933460	DVFX, MODEL M256	Apr 07, 1994	Substantially Equivalent	Xre Corp.
K933664	POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)	Dec 15, 1993	Substantially Equivalent	Siemens Gammasonics, Inc.
K934496	X-RAY ANGIOGRAPHIC SYSTEM	Dec 13, 1993	Substantially Equivalent	Camtronics, Ltd.
K932410	HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY	Dec 13, 1993	Substantially Equivalent	Heartware Intl. Corp.
K931184	MULTI-VIEW PROCESSOR (MVP)	Nov 02, 1993	Substantially Equivalent	Adac Laboratories
K933073	HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE	Oct 07, 1993	Substantially Equivalent	Heartware Intl. Corp.
K933058	HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW	Sep 28, 1993	Substantially Equivalent	Heartware Intl. Corp.
K930635	MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM	Sep 07, 1993	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K931170	SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS)	Jun 14, 1993	Substantially Equivalent	Sony Medical Systems
K926258	DLX	Mar 15, 1993	Substantially Equivalent	GE Medical Systems
K925961	OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM	Mar 02, 1993	Substantially Equivalent	Diagnostic Archives, Inc.
K926082	CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT	Dec 30, 1992	Substantially Equivalent	Biodan Medical Systems, Ltd.
K924719	ANCOR	Dec 30, 1992	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K924708	CINENET CARDIAC IMAGE NETWORK	Dec 30, 1992	Substantially Equivalent	Sony Medical Systems
K924137	CSP-A (CEILING SUSPENDED POSITIONER-ANGIO)	Dec 28, 1992	Substantially Equivalent	Fischer Imaging Corp.
K924828	BI-N	Dec 17, 1992	Substantially Equivalent	Xre Corp.
K922222	ANGIOGRAPHIC X-RAY SYSTEM	Dec 02, 1992	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K923654	POLY DIAGNOST CDX	Nov 20, 1992	Substantially Equivalent	Xre Corp.
K923813	PHILIPS INTEGRIS V3000 ROTATIONAL ANGIO FUNCTION	Oct 16, 1992	Substantially Equivalent	Philips Medical Systems, Inc.
K920862	BCM-400C	Sep 30, 1992	Substantially Equivalent	B C Medical , Ltd.
K923112	ANGIO-BAND	Sep 23, 1992	Substantially Equivalent	Cook, Inc.
K922804	AWOS ANGIOGRAPHIC WORKSTATION	Aug 28, 1992	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K922622	PHILIPS CARDIAC WORKSTATION	Aug 11, 1992	Substantially Equivalent	Philips Medical Systems, Inc.
K921101	PHILIPS INTEGRIS V3000 FILM	May 15, 1992	Substantially Equivalent	Philips Medical Systems, Inc.
K920705	POLYTRON DIGITAL IMAGING SYSTEM	Apr 27, 1992	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K920434	ATLAS 2000 VASCULAR ROAD MAPPING SYSTEM	Apr 13, 1992	Substantially Equivalent	Squires & Assoc., Inc.
K914376	DXS DIGITAL X-RAY SUBTRACTION	Feb 04, 1992	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K915199	STORZ IMAGING SYSTEM	Jan 23, 1992	Substantially Equivalent	Fischer Imaging Corp.
K915232	GRUNDIG ELECTRONICS VARIOUS MODELS	Jan 09, 1992	Substantially Equivalent	Perkins Mfg. Co.
K914313	HICOR	Nov 27, 1991	Substantially Equivalent	Siemens Gammasonics, Inc.
K913685	UNICATH EP.	Nov 07, 1991	Substantially Equivalent	Xre Corp.
K911732	ADVANCE DISPOSABLE CONTROL SYRINGE	Sep 16, 1991	Substantially Equivalent	Advance Medical Designs, Inc.
K912416	ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM	Aug 28, 1991	Substantially Equivalent	Xre Corp.
K913120	POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM	Aug 16, 1991	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K905518	BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET	Jun 21, 1991	Substantially Equivalent	Venusa , Ltd.
K910654	CINEMEASURE (TM)	Jun 06, 1991	Substantially Equivalent	Syracuse Research Corp.
K910370	PHILIPS INTEGRIS V3000 AND V4000	May 28, 1991	Substantially Equivalent	Philips Medical Systems, Inc.
K905653	ADVANTX AFM ANGIO SYSTEM S1808	May 15, 1991	Substantially Equivalent	GE Medical Systems
K903493	NAMIC CONTRAST SAVINGS DELIVERY SYSTEM	Mar 26, 1991	Substantially Equivalent	North American Instrument Corp.
K903941	SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400	Feb 04, 1991	Substantially Equivalent	Shimadzu Medical Systems
K903373	CATHETERIZATION C-ARM SUPPORT MH-51C(F)	Nov 29, 1990	Substantially Equivalent	Shimadzu Medical Systems
K903372	CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A	Nov 29, 1990	Substantially Equivalent	Shimadzu Medical Systems
K903371	CATHETERIZATION C-ARM SUPPORT MH-51B(F)	Nov 29, 1990	Substantially Equivalent	Shimadzu Medical Systems
K904540	VIDEO SYSTEM INTERFACE MODELS	Oct 26, 1990	Substantially Equivalent	Perkins Mfg. Co.
K904447	SONY CINE VIDEO SYSTEM SME-3500	Oct 17, 1990	Substantially Equivalent	Sony Medical Electronics Co.
K903375	HICOR	Oct 01, 1990	Substantially Equivalent	Siemens Gammasonics, Inc.
K902542	PHILIPS INTEGRIS C2000 SYSTEM	Aug 17, 1990	Substantially Equivalent	Philips Medical Systems North America, Inc.
K897115	ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)	Mar 13, 1990	Substantially Equivalent	Toshiba America Medical Systems, In.C
K896088	FEMORAL ANGIOGRAPHY DRAPE	Nov 17, 1989	Substantially Equivalent	Medical Plastics, Inc.
K892849	UNICATH A	Aug 09, 1989	Substantially Equivalent	Xre Corp.
K890348	LC, CARDIAC POSITIONER #B5078A	Feb 27, 1989	Substantially Equivalent	General Electric Co.
K890352	MULTISKOP	Feb 22, 1989	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K884912	ANGIOSTAR	Feb 16, 1989	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K884008	SONY CINE VIDEO SYSTEM SME-3300	Nov 30, 1988	Substantially Equivalent	Sony Medical Electronics Co.
K883860	ADVANTAGE	Nov 21, 1988	Substantially Equivalent	Fischer Imaging Corp.
K883831	IMAGER	Nov 21, 1988	Substantially Equivalent	Fischer Imaging Corp.
K880690	SIEMENS PACS/I-A	Oct 31, 1988	Substantially Equivalent	Siemens Gammasonics, Inc.
K882358	PULSED FLUOROSCOPIC CONTROL MODEL:PF-02	Oct 19, 1988	Substantially Equivalent	U.S. Imaging, Inc.
K883072	DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM	Sep 14, 1988	Substantially Equivalent	Siemens Gammasonics, Inc.
K874910	SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200	Jul 01, 1988	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K875380	SHIMADZU CATHETERIZATION C-ARM STAND MH-10	Feb 12, 1988	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K875379	SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A	Feb 12, 1988	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K875376	SHIMADZU CATHETERIZATION C-ARM STAND MH-50B	Feb 12, 1988	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K875375	SHIMADZU LATERAL C-ARM MH-30	Feb 12, 1988	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K875374	SHIMADZU CEILING-SUSPENDED C-ARM CH-50	Feb 12, 1988	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K875373	C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-20	Feb 12, 1988	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K875372	SHIMADZU CATHETERIZATION C-ARM STAND ER-200	Feb 12, 1988	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K875184	UNICATH LAB	Jan 29, 1988	Substantially Equivalent	Xre Corp.
K852331	SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC	Aug 01, 1986	Substantially Equivalent	Scholten Surgical Instruments, Inc.
K853044	STERICOVER	Nov 01, 1985	Substantially Equivalent	Sterimed, Inc.
K850455	QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM	May 06, 1985	Substantially Equivalent	Xre Corp.
K842495	MATRIX VIDEO IMAGER 1020 COMPACT CAMER	Aug 17, 1984	Substantially Equivalent	Matrix Instruments
K842494	MATRIS INSTRU. VIDEO IMAGER 1010-	Aug 17, 1984	Substantially Equivalent	Matrix Instruments
K834496	ISOREX LS-36	Feb 21, 1984	Substantially Equivalent	Elscint, Inc.
K813588	CTF MODEL 9300	Feb 04, 1982	Substantially Equivalent	Thomson-Csf Broadcast, Inc.
K812913	OMEGA II ANGIOGRAPHIC TABLE	Nov 24, 1981	Substantially Equivalent	General Electric Co.
K812721	DIGITRON	Nov 04, 1981	Substantially Equivalent	Siemens Corp.
K812238	D.I.V.A.S.	Sep 11, 1981	Substantially Equivalent	Cgr Medical Corp.
K811149	PANDOROS 1200A	Jun 09, 1981	Substantially Equivalent	Siemens Corp.
K810183	PRO-TOP-ANGIO SHIFT TABLE TOP EXTENSION	Feb 25, 1981	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K781991	ANGIOSKIP	Dec 07, 1978	Substantially Equivalent	Siemens Corp.