FDA Product Code
FDA Product Code IZI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1600
510(k) Clearances — 199 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | Stryker Endoscopy | 2026-05-28 | Traditional | PDF ↗ |
| K253181 | SURGIMAGE SIM 1000H Fluorescence Imaging Platform | Surgimage Corporation | 2026-05-13 | Traditional | PDF ↗ |
| K243645 | IC-Flow Imaging System 2.0 | Diagnostic Green GmbH | 2025-09-22 | Traditional | PDF ↗ |
| K243077 | Affirm 800 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2025-06-27 | Traditional | PDF ↗ |
| K231986 | Modus IR | Synaptive Medical, Inc. | 2024-03-25 | Traditional | PDF ↗ |
| K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | Surgvision GmbH | 2024-03-20 | Traditional | PDF ↗ |
| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | Carl Zeiss Meditec, Inc. | 2023-06-20 | Traditional | PDF ↗ |
| K230727 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc (A Part of Stryker) | 2023-06-05 | Traditional | PDF ↗ |
| K222240 | EXPLORER AIR® II | Surgvision GmbH | 2023-02-28 | Traditional | PDF ↗ |
| K214097 | Explorer Air II | Surgvision GmbH | 2022-02-25 | Traditional | PDF ↗ |
| K202391 | DIR 800 | Aesculap, Inc. | 2021-01-21 | Traditional | PDF ↗ |
| K192761 | Asimov-MKS Imaging System | Onlume, Inc. | 2020-01-17 | Traditional | PDF ↗ |
| K190772 | SURGICAL MICROSCOPE SYSTEM ORBEYE with IR | Olympus Medical Systems Corp. | 2019-10-10 | Traditional | PDF ↗ |
| K182907 | SPY Elite Intraoperative Perfusion Assessment System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-01-23 | Traditional | PDF ↗ |
| K181537 | GLOW800 | Leica Microsystems (Schweiz) AG | 2018-09-07 | Traditional | PDF ↗ |
| K180019 | CAAS Workstation | Pie Medical Imaging BV | 2018-05-03 | Traditional | PDF ↗ |
| K162991 | YELLOW 560 Fluorescence Module | Carl Zeiss Meditec, AG | 2017-07-24 | Traditional | PDF ↗ |
| K170239 | Leica FL560 | Leica Microsystems (Schweiz) AG | 2017-07-05 | Traditional | PDF ↗ |
| K151780 | CAAS Workstation | Pie Medical Imaging BV | 2016-03-11 | Traditional | PDF ↗ |
| K141136 | LEICA FL800 | Leica Biosystems Richmond | 2014-08-19 | Traditional | PDF ↗ |
| K133719 | PDE-NEO | Hamamatsu Photonics K.K. | 2014-03-27 | Traditional | PDF ↗ |
| K133993 | CAAS WORKSTATION | Pie Medical Imaging | 2014-03-25 | Traditional | PDF ↗ |
| K130003 | XIRALITE FLOURESCENCE IMAGING SYSTEM X4 | Mivenion GmbH | 2014-01-31 | Traditional | PDF ↗ |
| K130842 | ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES | Philips Medical Systems Nederland B.V. | 2013-05-21 | Traditional | PDF ↗ |
| K113594 | C-THV SYSTEM | Paieon, Inc. | 2012-03-02 | Traditional | PDF ↗ |
| K113034 | GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM | GE Healthcare | 2011-12-13 | Traditional | PDF ↗ |
| K111209 | INTEGRATED INNOVA - S5I SYSTEM OPTION | GE Healthcare | 2011-07-26 | Traditional | PDF ↗ |
| K110256 | THE IC-PRO SYSTEM | Paieon, Inc. | 2011-05-27 | Traditional | PDF ↗ |
| K100371 | SPY INTRA-OPERATIVE IMAGING SYSTEM | Novadaq Technologies, Inc. | 2011-02-04 | Traditional | PDF ↗ |
| K100849 | SYNC-RX SYSTEM, MODEL AS00010 | Sync-Rx, Ltd. | 2010-05-21 | Traditional | PDF ↗ |
| K100468 | ZEISS INFRARED 800 WITH FLOW 800 OPTION | Carl Zeiss Surgical GmbH | 2010-03-03 | Traditional | PDF ↗ |
| K090745 | ARTIS ZEE / ZEEGOS WITH SW VC14 | Siemens Medical Solutions USA, Inc. | 2009-06-18 | Traditional | PDF ↗ |
| K083745 | THE IC-PRO SYSTEM, MODEL VERSION 3.2 | Paieon, Inc. | 2009-02-17 | Traditional | PDF ↗ |
| K082907 | IC-PRO SYSTEM, VERSION 3.1.0.4 | Paieon, Inc. | 2008-11-18 | Traditional | PDF ↗ |
| K073328 | CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA | Paieon, Inc. | 2008-09-09 | Traditional | PDF ↗ |
| K080612 | LEICA FL800 | Leica Microsystems (Schweiz) AG | 2008-05-09 | Traditional | PDF ↗ |
| K073290 | ARTIS ZEE AND ZEEGO | Siemens Medical Solutions USA, Inc. | 2008-02-11 | Traditional | PDF ↗ |
| K073130 | SPY FLUORESCENT IMAGING SYSTEM | Novadaq Technologies, Inc. | 2008-01-10 | Traditional | PDF ↗ |
| K073088 | SPY FLUORESCENT IMAGING SYSTEM | Novadaq Technologies, Inc. | 2008-01-10 | Traditional | PDF ↗ |
| K071619 | SPY FLUORESCENT IMAGING SYSTEM | Novadaq Technologies, Inc. | 2007-11-09 | Traditional | PDF ↗ |
| K072591 | CARDIOP-B SYSTEM, VERSION 2.1 | Paieon, Inc. | 2007-10-10 | Special | PDF ↗ |
| K072222 | SPY FLUORESCENT IMAGING SYSTEM | Novadaq Technologies, Inc. | 2007-09-07 | Special | PDF ↗ |
| K072006 | DAR-9400F | Shimadzu Corp. | 2007-08-31 | Abbreviated | PDF ↗ |
| K071717 | GE OEC ALTITUDE | Shimadzu Corp. | 2007-07-05 | Traditional | PDF ↗ |
| K071037 | SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 | Novadaq Technologies, Inc. | 2007-05-10 | Special | PDF ↗ |
| K063345 | SPY IMAGING SYSTEM | Novadaq Technologies, Inc. | 2007-01-12 | Traditional | PDF ↗ |
| K062360 | BRANSIST SAFIRE | Shimadzu Corp. | 2006-10-05 | Abbreviated | PDF ↗ |
| K061871 | LEICA MODEL FL800 | Leica Microsystems, Inc. | 2006-09-20 | Traditional | PDF ↗ |
| K060867 | SPY INTRAOPERATIVE IMAGING SYSTEM | Novadaq Technologies, Inc. | 2006-05-03 | Traditional | PDF ↗ |
| K060749 | XPERCT | Philips Medical Systems North America Co. | 2006-04-04 | Traditional | PDF ↗ |
| K052500 | DAR-8000F | Shimadzu Medical Systems | 2005-10-17 | Abbreviated | PDF ↗ |
| K052076 | DAR-8000I | Shimadzu Medical Systems | 2005-09-02 | Abbreviated | PDF ↗ |
| K052039 | GE OEC ALTITUDE | Ge Oec Medical Systems | 2005-08-11 | Abbreviated | PDF ↗ |
| K042961 | SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000 | Novadaq Technologies, Inc. | 2005-01-19 | Traditional | PDF ↗ |
| K042646 | DYNACT | Siemens Medical Systems, Inc. | 2004-10-19 | Special | PDF ↗ |
| K041949 | ALLURA XPER FD10 | Philips Medical Systems North America Co. | 2004-07-30 | Traditional | PDF ↗ |
| K041027 | DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D | Toshibamedical Systems Corporation | 2004-05-14 | Traditional | PDF ↗ |
| K030139 | THE CARDIOP-B SYSTEM | Paieon, Inc. | 2004-04-02 | Traditional | PDF ↗ |
| K032443 | DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE | Shimadzu Corp. | 2004-02-20 | Abbreviated | PDF ↗ |
| K033184 | LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400 | Shimadzu Corp. | 2003-12-09 | Traditional | PDF ↗ |
| K031333 | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 | Philips Medical Systems North America, Inc. | 2003-05-13 | Traditional | PDF ↗ |
| K023970 | QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS | Medis Medical Imaging Systems BV | 2003-01-24 | Traditional | PDF ↗ |
| K023441 | PHILIPS MULTIDIAGNOST ELEVA | Philips Medical Systems | 2002-10-30 | Traditional | PDF ↗ |
| K010721 | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM | Siemens Medical Corp. | 2001-03-30 | Traditional | PDF ↗ |
| K010391 | ATLAS MULTI-PURPOSE DSA SYSTEM | Cares Built, Inc. | 2001-03-12 | Traditional | PDF ↗ |
| K002840 | MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM | The Phantom Laboratory, Inc. | 2000-11-17 | Traditional | PDF ↗ |
| K993947 | KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY | Siemens Corp. | 1999-12-21 | Traditional | PDF ↗ |
| K993765 | QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV) | Medis Medical Imaging Systems BV | 1999-11-26 | Special | PDF ↗ |
| K993763 | QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) | Medis Medical Imaging Systems BV | 1999-11-26 | Special | PDF ↗ |
| K991922 | DIGITAL IMAGING SYSTEM (BSR) | Siemens Medical Solutions USA, Inc. | 1999-09-01 | Traditional | PDF ↗ |
| K991231 | HITACHI VERSIFLEX | Hitachi Medical Systems America, Inc. | 1999-05-24 | Traditional | PDF ↗ |
| K984545 | RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS | Philips Medical Systems North America, Inc. | 1999-02-25 | Traditional | PDF ↗ |
| K983877 | PHILIPS INTEGRIS 3D RA OPTION | Philips Medical Systems North America, Inc. | 1998-12-21 | Traditional | PDF ↗ |
| K982203 | CAAS II LVA BIPLANE OPTION | Pie Medical Equipment B.V. | 1998-07-14 | Traditional | PDF ↗ |
| K974679 | THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM | Medcon , Ltd. | 1998-03-23 | Traditional | PDF ↗ |
| K974367 | ADVANTX LCN, ADVANTX LCLP | GE Medical Systems | 1998-02-13 | Traditional | PDF ↗ |
| K973270 | LEG'MAP OPTION | Ge Medical Systems, Inc. | 1997-11-25 | Traditional | PDF ↗ |
| K973482 | PHILIPS INTEGRIS V5000 AND BV5000 | Philips Medical Systems North America, Inc. | 1997-11-10 | Traditional | PDF ↗ |
| K972655 | CONTROL SYRINGE | Medical Specialties Intl., Inc. | 1997-11-04 | Traditional | PDF ↗ |
| K973368 | STRAIT'MAP OPTION | Ge Medical Systems, Inc. | 1997-10-17 | Traditional | PDF ↗ |
| K972229 | IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM | Heartware, Inc. | 1997-10-16 | Traditional | PDF ↗ |
| K973342 | DAR-3000B | Shimadzu Corp. | 1997-10-08 | Traditional | PDF ↗ |
| K971176 | VIEW ARCHIVING STATION | Electromed Intl., Ltd. | 1997-09-03 | Traditional | PDF ↗ |
| K971181 | THE MIDVIEW-MEDCON'S DICOM VIEWER | Medcon , Ltd. | 1997-07-29 | Traditional | PDF ↗ |
| K971489 | RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4 | Philips Medical Systems North America, Inc. | 1997-07-03 | Traditional | PDF ↗ |
| K972136 | TV MONITOR (P12/17) | Perkins Mfg. Co. | 1997-06-26 | Traditional | PDF ↗ |
| K971365 | PHILIPS INTEGRIS H5000 | Philips Medical Systems North America, Inc. | 1997-05-14 | Traditional | PDF ↗ |
| K970738 | KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT | Jamieson Film Co. | 1997-05-07 | Traditional | PDF ↗ |
| K970525 | STATNET | Gorca Systems, Inc. | 1997-04-16 | Traditional | PDF ↗ |
| K955179 | CONTRAST MEDIA SET | B.Braun Medical, Inc. | 1997-03-12 | Traditional | PDF ↗ |
| K961451 | DICOMNET | Lockheed Martin Communications Systems | 1996-07-03 | Traditional | PDF ↗ |
| K955519 | ANALYTICAL REVIEW STATION | Camtronics, Ltd. | 1996-05-09 | Traditional | PDF ↗ |
| K960575 | ADVANTX LCV+ | GE Medical Systems | 1996-05-07 | Traditional | PDF ↗ |
| K954581 | ARC SERIES | Continental X-Ray Corp. | 1995-12-21 | Traditional | PDF ↗ |
| K955395 | DAR-2400-15B/30B | Shimadzu Medical Systems | 1995-12-11 | Traditional | PDF ↗ |
| K945400 | HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 | Hitachi Medical Corp. of America | 1995-11-20 | Traditional | PDF ↗ |
| K954309 | ANGIOREX | Toshiba Medical Systems | 1995-10-06 | Traditional | PDF ↗ |
| K953563 | VANGUARD XR-350 CINEANGIOGRAM PROJECTOR | Jamieson Film Co. | 1995-10-05 | Traditional | PDF ↗ |
| K952704 | PHILIPS EASYVISION | Philips Medical Systems, Inc. | 1995-07-03 | Traditional | PDF ↗ |
| K945540 | CAAS II | Pie Medical Equipment B.V. | 1995-06-28 | Traditional | PDF ↗ |
Product code IZI · Class II · Radiology. Data: openFDA.