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System, X-Ray, Angiographic

FDA product code IZI · 195 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1600
Review panel: RA
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-12-07 – 2026-05-28

IZI 1995-01-30

DLX

Applicant General Electric Co.

K number K945459

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IZI 1995-01-30

ADVANTX LCA

Applicant GE Medical Systems

K number K945375

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IZI 1995-01-05

TOP ACOM STATION

Applicant Siemens Medical Solutions USA, Inc.

K number K945293

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IZI 1994-12-09

COMPAS

Applicant General Electric Co.

K number K945483

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IZI 1994-11-07

GEMNET

Applicant GE Medical Systems

K number K943355

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IZI 1994-09-29

CARDIOVASCULAR MEASUREMENT SYSTEM-CMS

Applicant Medis Medical Imaging Systems, Inc.

K number K940172

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IZI 1994-09-09

CINEMAC QAS

Applicant Xre Corp.

K number K936002

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IZI 1994-08-24

DIGITAL MEDIA CONVERTER (D-MC)

Applicant Eigen Video

K number K935026

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IZI 1994-08-17

VIDEO PLUS WITH ANALYTICAL WORKSTATION

Applicant Camtronics, Ltd.

K number K941979

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IZI 1994-07-20

UNICATH FAMILY

Applicant Angiographic Devices Corp.

K number K942503

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IZI 1994-07-18

ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION

Applicant GE Medical Systems

K number K942120

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IZI 1994-06-06

ANGIOREX CAS-05A

Applicant Toshiba America Medical Systems, In.C

K number K941177

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IZI 1994-05-20

LCA ANGIOGRAPHIC IMAGING SYSTEM

Applicant GE Medical Systems

K number K941946

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IZI 1994-04-19

COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K940484

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IZI 1994-04-07

DVFX, MODEL M256

Applicant Xre Corp.

K number K933460

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IZI 1993-12-15

POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)

Applicant Siemens Gammasonics, Inc.

K number K933664

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IZI 1993-12-13

X-RAY ANGIOGRAPHIC SYSTEM

Applicant Camtronics, Ltd.

K number K934496

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IZI 1993-12-13

HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY

Applicant Heartware Intl. Corp.

K number K932410

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IZI 1993-11-02

MULTI-VIEW PROCESSOR (MVP)

Applicant Adac Laboratories

K number K931184

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IZI 1993-10-07

HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE

Applicant Heartware Intl. Corp.

K number K933073

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IZI 1993-09-28

HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW

Applicant Heartware Intl. Corp.

K number K933058

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IZI 1993-09-07

MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K930635

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IZI 1993-06-14

SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS)

Applicant Sony Medical Systems

K number K931170

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IZI 1993-03-15

DLX

Applicant GE Medical Systems

K number K926258

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IZI 1993-03-02

OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM

Applicant Diagnostic Archives, Inc.

K number K925961

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IZI 1992-12-30

CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT

Applicant Biodan Medical Systems, Ltd.

K number K926082

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IZI 1992-12-30

ANCOR

Applicant Siemens Medical Solutions USA, Inc.

K number K924719

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IZI 1992-12-30

CINENET CARDIAC IMAGE NETWORK

Applicant Sony Medical Systems

K number K924708

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IZI 1992-12-28

CSP-A (CEILING SUSPENDED POSITIONER-ANGIO)

Applicant Fischer Imaging Corp.

K number K924137

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IZI 1992-12-17

BI-N

Applicant Xre Corp.

K number K924828

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IZI 1992-12-02

ANGIOGRAPHIC X-RAY SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K922222

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IZI 1992-11-20

POLY DIAGNOST CDX

Applicant Xre Corp.

K number K923654

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IZI 1992-10-16

PHILIPS INTEGRIS V3000 ROTATIONAL ANGIO FUNCTION

Applicant Philips Medical Systems, Inc.

K number K923813

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IZI 1992-09-30

BCM-400C

Applicant B C Medical , Ltd.

K number K920862

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IZI 1992-09-23

ANGIO-BAND

Applicant Cook, Inc.

K number K923112

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IZI 1992-08-28

AWOS ANGIOGRAPHIC WORKSTATION

Applicant Siemens Medical Solutions USA, Inc.

K number K922804

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IZI 1992-08-11

PHILIPS CARDIAC WORKSTATION

Applicant Philips Medical Systems, Inc.

K number K922622

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IZI 1992-05-15

PHILIPS INTEGRIS V3000 FILM

Applicant Philips Medical Systems, Inc.

K number K921101

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IZI 1992-04-27

POLYTRON DIGITAL IMAGING SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K920705

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IZI 1992-04-13

ATLAS 2000 VASCULAR ROAD MAPPING SYSTEM

Applicant Squires & Assoc., Inc.

K number K920434

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IZI 1992-02-04

DXS DIGITAL X-RAY SUBTRACTION

Applicant Philips Medical Systems (Cleveland), Inc.

K number K914376

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IZI 1992-01-23

STORZ IMAGING SYSTEM

Applicant Fischer Imaging Corp.

K number K915199

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IZI 1992-01-09

GRUNDIG ELECTRONICS VARIOUS MODELS

Applicant Perkins Mfg. Co.

K number K915232

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IZI 1991-11-27

HICOR

Applicant Siemens Gammasonics, Inc.

K number K914313

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IZI 1991-11-07

UNICATH EP.

Applicant Xre Corp.

K number K913685

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IZI 1991-09-16

ADVANCE DISPOSABLE CONTROL SYRINGE

Applicant Advance Medical Designs, Inc.

K number K911732

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IZI 1991-08-28

ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM

Applicant Xre Corp.

K number K912416

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IZI 1991-08-16

POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K913120

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IZI 1991-06-21

BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET

Applicant Venusa , Ltd.

K number K905518

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IZI 1991-06-06

CINEMEASURE (TM)

Applicant Syracuse Research Corp.

K number K910654

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IZI 1991-05-28

PHILIPS INTEGRIS V3000 AND V4000

Applicant Philips Medical Systems, Inc.

K number K910370

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IZI 1991-05-15

ADVANTX AFM ANGIO SYSTEM S1808

Applicant GE Medical Systems

K number K905653

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IZI 1991-03-26

NAMIC CONTRAST SAVINGS DELIVERY SYSTEM

Applicant North American Instrument Corp.

K number K903493

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IZI 1991-02-04

SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400

Applicant Shimadzu Medical Systems

K number K903941

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IZI 1990-11-29

CATHETERIZATION C-ARM SUPPORT MH-51C(F)

Applicant Shimadzu Medical Systems

K number K903373

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IZI 1990-11-29

CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A

Applicant Shimadzu Medical Systems

K number K903372

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IZI 1990-11-29

CATHETERIZATION C-ARM SUPPORT MH-51B(F)

Applicant Shimadzu Medical Systems

K number K903371

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IZI 1990-10-26

VIDEO SYSTEM INTERFACE MODELS

Applicant Perkins Mfg. Co.

K number K904540

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IZI 1990-10-17

SONY CINE VIDEO SYSTEM SME-3500

Applicant Sony Medical Electronics Co.

K number K904447

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IZI 1990-10-01

HICOR

Applicant Siemens Gammasonics, Inc.

K number K903375

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IZI 1990-08-17

PHILIPS INTEGRIS C2000 SYSTEM

Applicant Philips Medical Systems North America, Inc.

K number K902542

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IZI 1990-03-13

ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)

Applicant Toshiba America Medical Systems, In.C

K number K897115

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IZI 1989-11-17

FEMORAL ANGIOGRAPHY DRAPE

Applicant Medical Plastics, Inc.

K number K896088

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IZI 1989-08-09

UNICATH A

Applicant Xre Corp.

K number K892849

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IZI 1989-02-27

LC, CARDIAC POSITIONER #B5078A

Applicant General Electric Co.

K number K890348

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IZI 1989-02-22

MULTISKOP

Applicant Siemens Medical Solutions USA, Inc.

K number K890352

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IZI 1989-02-16

ANGIOSTAR

Applicant Siemens Medical Solutions USA, Inc.

K number K884912

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IZI 1988-11-30

SONY CINE VIDEO SYSTEM SME-3300

Applicant Sony Medical Electronics Co.

K number K884008

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IZI 1988-11-21

ADVANTAGE

Applicant Fischer Imaging Corp.

K number K883860

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IZI 1988-11-21

IMAGER

Applicant Fischer Imaging Corp.

K number K883831

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IZI 1988-10-31

SIEMENS PACS/I-A

Applicant Siemens Gammasonics, Inc.

K number K880690

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IZI 1988-10-19

PULSED FLUOROSCOPIC CONTROL MODEL:PF-02

Applicant U.S. Imaging, Inc.

K number K882358

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IZI 1988-09-14

DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM

Applicant Siemens Gammasonics, Inc.

K number K883072

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IZI 1988-07-01

SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200

Applicant Shimadzu Precision Instruments, Inc.

K number K874910

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IZI 1988-02-12

SHIMADZU CATHETERIZATION C-ARM STAND MH-10

Applicant Shimadzu Precision Instruments, Inc.

K number K875380

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IZI 1988-02-12

SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A

Applicant Shimadzu Precision Instruments, Inc.

K number K875379

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IZI 1988-02-12

SHIMADZU CATHETERIZATION C-ARM STAND MH-50B

Applicant Shimadzu Precision Instruments, Inc.

K number K875376

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IZI 1988-02-12

SHIMADZU LATERAL C-ARM MH-30

Applicant Shimadzu Precision Instruments, Inc.

K number K875375

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IZI 1988-02-12

SHIMADZU CEILING-SUSPENDED C-ARM CH-50

Applicant Shimadzu Precision Instruments, Inc.

K number K875374

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IZI 1988-02-12

C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-20

Applicant Shimadzu Precision Instruments, Inc.

K number K875373

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IZI 1988-02-12

SHIMADZU CATHETERIZATION C-ARM STAND ER-200

Applicant Shimadzu Precision Instruments, Inc.

K number K875372

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IZI 1988-01-29

UNICATH LAB

Applicant Xre Corp.

K number K875184

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IZI 1986-08-01

SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC

Applicant Scholten Surgical Instruments, Inc.

K number K852331

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IZI 1985-11-01

STERICOVER

Applicant Sterimed, Inc.

K number K853044

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IZI 1985-05-06

QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM

Applicant Xre Corp.

K number K850455

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IZI 1984-08-17

MATRIX VIDEO IMAGER 1020 COMPACT CAMER

Applicant Matrix Instruments

K number K842495

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IZI 1984-08-17

MATRIS INSTRU. VIDEO IMAGER 1010-

Applicant Matrix Instruments

K number K842494

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IZI 1984-02-21

ISOREX LS-36

Applicant Elscint, Inc.

K number K834496

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IZI 1982-02-04

CTF MODEL 9300

Applicant Thomson-Csf Broadcast, Inc.

K number K813588

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IZI 1981-11-24

OMEGA II ANGIOGRAPHIC TABLE

Applicant General Electric Co.

K number K812913

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IZI 1981-11-04

DIGITRON

Applicant Siemens Corp.

K number K812721

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IZI 1981-09-11

D.I.V.A.S.

Applicant Cgr Medical Corp.

K number K812238

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IZI 1981-06-09

PANDOROS 1200A

Applicant Siemens Corp.

K number K811149

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IZI 1981-02-25

PRO-TOP-ANGIO SHIFT TABLE TOP EXTENSION

Applicant Philips Medical Systems (Cleveland), Inc.

K number K810183

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IZI 1978-12-07

ANGIOSKIP

Applicant Siemens Corp.

K number K781991

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