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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 2026-05-28

780 nm SPY Portable Handheld Imaging (SPY-PHI) System

Applicant Stryker Endoscopy

K number K261037

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IZI 2026-05-13

SURGIMAGE SIM 1000H Fluorescence Imaging Platform

Applicant Surgimage Corporation

K number K253181

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IZI 2025-09-22

IC-Flow™ Imaging System 2.0

Applicant Diagnostic Green GmbH

K number K243645

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IZI 2025-06-27

Affirm 800

Applicant Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)

K number K243077

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IZI 2024-03-25

Modus IR

Applicant Synaptive Medical, Inc.

K number K231986

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IZI 2024-03-20

EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)

Applicant Surgvision GmbH

K number K234090

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IZI 2023-06-20

Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)

Applicant Carl Zeiss Meditec, Inc.

K number K231075

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IZI 2023-06-05

SPY Portable Handheld Imaging (SPY-PHI) System

Applicant Novadaq Technologies Ulc (A Part of Stryker)

K number K230727

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IZI 2023-02-28

EXPLORER AIR® II

Applicant Surgvision GmbH

K number K222240

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IZI 2022-02-25

Explorer Air II

Applicant Surgvision GmbH

K number K214097

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IZI 2021-01-21

DIR 800

Applicant Aesculap, Inc.

K number K202391

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IZI 2020-01-17

Asimov-MKS Imaging System

Applicant Onlume, Inc.

K number K192761

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IZI 2019-10-10

SURGICAL MICROSCOPE SYSTEM ORBEYE with IR

Applicant Olympus Medical Systems Corp.

K number K190772

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IZI 2019-01-23

SPY Elite Intraoperative Perfusion Assessment System

Applicant Novadaq Technologies Ulc. (Now A Part of Stryker)

K number K182907

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IZI 2018-09-07

GLOW800

Applicant Leica Microsystems (Schweiz) AG

K number K181537

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IZI 2018-05-03

CAAS Workstation

Applicant Pie Medical Imaging BV

K number K180019

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IZI 2017-07-24

YELLOW 560 Fluorescence Module

Applicant Carl Zeiss Meditec, AG

K number K162991

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IZI 2017-07-05

Leica FL560

Applicant Leica Microsystems (Schweiz) AG

K number K170239

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IZI 2016-03-11

CAAS Workstation

Applicant Pie Medical Imaging BV

K number K151780

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IZI 2013-05-21

ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES

Applicant Philips Medical Systems Nederland B.V.

K number K130842

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IZI 2012-03-02

C-THV SYSTEM

Applicant Paieon, Inc.

K number K113594

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IZI 2011-12-13

GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM

Applicant GE Healthcare

K number K113034

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IZI 2011-07-26

INTEGRATED INNOVA - S5I SYSTEM OPTION

Applicant GE Healthcare

K number K111209

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IZI 2011-05-27

THE IC-PRO SYSTEM

Applicant Paieon, Inc.

K number K110256

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IZI 2011-02-04

SPY INTRA-OPERATIVE IMAGING SYSTEM

Applicant Novadaq Technologies, Inc.

K number K100371

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IZI 2010-05-21

SYNC-RX SYSTEM, MODEL AS00010

Applicant Sync-Rx, Ltd.

K number K100849

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IZI 2010-03-03

ZEISS INFRARED 800 WITH FLOW 800 OPTION

Applicant Carl Zeiss Surgical GmbH

K number K100468

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IZI 2009-06-18

ARTIS ZEE / ZEEGOS WITH SW VC14

Applicant Siemens Medical Solutions USA, Inc.

K number K090745

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IZI 2009-02-17

THE IC-PRO SYSTEM, MODEL VERSION 3.2

Applicant Paieon, Inc.

K number K083745

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IZI 2008-11-18

IC-PRO SYSTEM, VERSION 3.1.0.4

Applicant Paieon, Inc.

K number K082907

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IZI 2008-09-09

CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA

Applicant Paieon, Inc.

K number K073328

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IZI 2008-05-09

LEICA FL800

Applicant Leica Microsystems (Schweiz) AG

K number K080612

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IZI 2008-02-11

ARTIS ZEE AND ZEEGO

Applicant Siemens Medical Solutions USA, Inc.

K number K073290

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IZI 2008-01-10

SPY FLUORESCENT IMAGING SYSTEM

Applicant Novadaq Technologies, Inc.

K number K073130

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IZI 2008-01-10

SPY FLUORESCENT IMAGING SYSTEM

Applicant Novadaq Technologies, Inc.

K number K073088

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IZI 2007-11-09

SPY FLUORESCENT IMAGING SYSTEM

Applicant Novadaq Technologies, Inc.

K number K071619

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IZI 2007-10-10

CARDIOP-B SYSTEM, VERSION 2.1

Applicant Paieon, Inc.

K number K072591

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IZI 2007-09-07

SPY FLUORESCENT IMAGING SYSTEM

Applicant Novadaq Technologies, Inc.

K number K072222

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IZI 2007-08-31

DAR-9400F

Applicant Shimadzu Corp.

K number K072006

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IZI 2007-07-05

GE OEC ALTITUDE

Applicant Shimadzu Corp.

K number K071717

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IZI 2007-05-10

SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000

Applicant Novadaq Technologies, Inc.

K number K071037

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IZI 2007-01-12

SPY IMAGING SYSTEM

Applicant Novadaq Technologies, Inc.

K number K063345

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IZI 2006-10-05

BRANSIST SAFIRE

Applicant Shimadzu Corp.

K number K062360

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IZI 2006-09-20

LEICA MODEL FL800

Applicant Leica Microsystems, Inc.

K number K061871

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IZI 2006-05-03

SPY INTRAOPERATIVE IMAGING SYSTEM

Applicant Novadaq Technologies, Inc.

K number K060867

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IZI 2006-04-04

XPERCT

Applicant Philips Medical Systems North America Co.

K number K060749

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IZI 2005-10-17

DAR-8000F

Applicant Shimadzu Medical Systems

K number K052500

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IZI 2005-09-02

DAR-8000I

Applicant Shimadzu Medical Systems

K number K052076

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IZI 2005-08-11

GE OEC ALTITUDE

Applicant Ge Oec Medical Systems

K number K052039

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IZI 2005-01-19

SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000

Applicant Novadaq Technologies, Inc.

K number K042961

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IZI 2004-10-19

DYNACT

Applicant Siemens Medical Systems, Inc.

K number K042646

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IZI 2004-07-30

ALLURA XPER FD10

Applicant Philips Medical Systems North America Co.

K number K041949

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IZI 2004-05-14

DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D

Applicant Toshibamedical Systems Corporation

K number K041027

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IZI 2004-04-02

THE CARDIOP-B SYSTEM

Applicant Paieon, Inc.

K number K030139

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IZI 2004-02-20

DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE

Applicant Shimadzu Corp.

K number K032443

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IZI 2003-12-09

LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400

Applicant Shimadzu Corp.

K number K033184

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IZI 2003-05-13

PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2

Applicant Philips Medical Systems North America, Inc.

K number K031333

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IZI 2003-01-24

QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS

Applicant Medis Medical Imaging Systems BV

K number K023970

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IZI 2002-10-30

PHILIPS MULTIDIAGNOST ELEVA

Applicant Philips Medical Systems

K number K023441

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IZI 2001-03-30

AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM

Applicant Siemens Medical Corp.

K number K010721

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IZI 2001-03-12

ATLAS MULTI-PURPOSE DSA SYSTEM

Applicant Cares Built, Inc.

K number K010391

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IZI 2000-11-17

MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM

Applicant The Phantom Laboratory, Inc.

K number K002840

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IZI 1999-12-21

KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY

Applicant Siemens Corp.

K number K993947

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IZI 1999-11-26

QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)

Applicant Medis Medical Imaging Systems BV

K number K993765

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IZI 1999-11-26

QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)

Applicant Medis Medical Imaging Systems BV

K number K993763

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IZI 1999-09-01

DIGITAL IMAGING SYSTEM (BSR)

Applicant Siemens Medical Solutions USA, Inc.

K number K991922

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IZI 1999-05-24

HITACHI VERSIFLEX

Applicant Hitachi Medical Systems America, Inc.

K number K991231

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IZI 1999-02-25

RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS

Applicant Philips Medical Systems North America, Inc.

K number K984545

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IZI 1998-12-21

PHILIPS INTEGRIS 3D RA OPTION

Applicant Philips Medical Systems North America, Inc.

K number K983877

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IZI 1998-07-14

CAAS II LVA BIPLANE OPTION

Applicant Pie Medical Equipment B.V.

K number K982203

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IZI 1998-03-23

THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM

Applicant Medcon , Ltd.

K number K974679

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IZI 1998-02-13

ADVANTX LCN, ADVANTX LCLP

Applicant GE Medical Systems

K number K974367

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IZI 1997-11-25

LEG'MAP OPTION

Applicant Ge Medical Systems, Inc.

K number K973270

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IZI 1997-11-10

PHILIPS INTEGRIS V5000 AND BV5000

Applicant Philips Medical Systems North America, Inc.

K number K973482

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IZI 1997-11-04

CONTROL SYRINGE

Applicant Medical Specialties Intl., Inc.

K number K972655

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IZI 1997-10-17

STRAIT'MAP OPTION

Applicant Ge Medical Systems, Inc.

K number K973368

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IZI 1997-10-16

IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM

Applicant Heartware, Inc.

K number K972229

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IZI 1997-10-08

DAR-3000B

Applicant Shimadzu Corp.

K number K973342

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IZI 1997-09-03

VIEW ARCHIVING STATION

Applicant Electromed Intl., Ltd.

K number K971176

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IZI 1997-07-29

THE MIDVIEW-MEDCON'S DICOM VIEWER

Applicant Medcon , Ltd.

K number K971181

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IZI 1997-07-03

RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4

Applicant Philips Medical Systems North America, Inc.

K number K971489

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IZI 1997-06-26

TV MONITOR (P12/17)

Applicant Perkins Mfg. Co.

K number K972136

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IZI 1997-05-14

PHILIPS INTEGRIS H5000

Applicant Philips Medical Systems North America, Inc.

K number K971365

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IZI 1997-05-07

KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT

Applicant Jamieson Film Co.

K number K970738

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IZI 1997-04-16

STATNET

Applicant Gorca Systems, Inc.

K number K970525

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IZI 1997-03-12

CONTRAST MEDIA SET

Applicant B.Braun Medical, Inc.

K number K955179

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IZI 1996-07-03

DICOMNET

Applicant Lockheed Martin Communications Systems

K number K961451

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IZI 1996-05-09

ANALYTICAL REVIEW STATION

Applicant Camtronics, Ltd.

K number K955519

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IZI 1996-05-07

ADVANTX LCV+

Applicant GE Medical Systems

K number K960575

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IZI 1995-12-21

ARC SERIES

Applicant Continental X-Ray Corp.

K number K954581

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IZI 1995-12-11

DAR-2400-15B/30B

Applicant Shimadzu Medical Systems

K number K955395

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IZI 1995-11-20

HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100

Applicant Hitachi Medical Corp. of America

K number K945400

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IZI 1995-10-06

ANGIOREX

Applicant Toshiba Medical Systems

K number K954309

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IZI 1995-10-05

VANGUARD XR-350 CINEANGIOGRAM PROJECTOR

Applicant Jamieson Film Co.

K number K953563

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IZI 1995-07-03

PHILIPS EASYVISION

Applicant Philips Medical Systems, Inc.

K number K952704

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IZI 1995-06-28

CAAS II

Applicant Pie Medical Equipment B.V.

K number K945540

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IZI 1995-05-04

BCM 400CP

Applicant B C Medical , Ltd.

K number K946378

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IZI 1995-02-27

UNICATH LLU ANGIOGRAPHIC SYSTEM

Applicant Xre Corp.

K number K945449

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IZI 1995-02-17

ANGIOGRAPHIC SYSTEM

Applicant Acoma Medical Imaging, Inc.

K number K944952

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IZI 1995-02-03

CEILING SUSPENDED C-ARM SUPPORT MH-100

Applicant Shimadzu Medical Systems

K number K943545

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