ClearanceBrief
Panels › Radiology › Product code IZI · Class 2

System, X-Ray, Angiographic

Regulation 892.1600

2510(k)s in 12 months (199 all time)
1recalls in 12 months (259 all time)
240recalls that name a 510(k)
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Top companies in IZI

Company510(k)sRecalls
Siemens Medical Solutions USA, Inc.1398
Philips Medical Systems North America Co. Phillips055
Philips Electronics North America Corporation034
GE Healthcare226
GE Medical Systems103
Shimadzu Medical Systems85
Novadaq Technologies, Inc.93
Philips Medical Systems64
Xre Corp.100
Philips Medical Systems North America Co.90
Decided510(k)Device and applicantCode
May 28, 2026K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) System
Stryker Endoscopy
IZI
May 13, 2026K253181SURGIMAGE SIM 1000H Fluorescence Imaging Platform
Surgimage Corporation, TW
IZI
Sep 22, 2025K243645IC-Flow™ Imaging System 2.0
Diagnostic Green GmbH, DE
IZI
Jun 27, 2025K243077Affirm 800
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
IZI
Mar 25, 2024K231986Modus IR
Synaptive Medical, Inc., CA
IZI
Mar 20, 2024K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
Surgvision GmbH, DE
IZI
Jun 20, 2023K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
Carl Zeiss Meditec, Inc.
IZI
Jun 5, 2023K230727SPY Portable Handheld Imaging (SPY-PHI) System
Novadaq Technologies Ulc (A Part of Stryker), CA
IZI
Feb 28, 2023K222240EXPLORER AIR® II
Surgvision GmbH, DE
IZI
Feb 25, 2022K214097Explorer Air II
Surgvision GmbH, DE
IZI
Jan 21, 2021K202391DIR 800
Aesculap, Inc.
IZI
Jan 17, 2020K192761Asimov-MKS Imaging System
Onlume, Inc.
IZI
Oct 10, 2019K190772SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
Olympus Medical Systems Corp., JP
IZI
Jan 23, 2019K182907SPY Elite Intraoperative Perfusion Assessment System
Novadaq Technologies Ulc. (Now A Part of Stryker), CA
IZI
Sep 7, 2018K181537GLOW800
Leica Microsystems (Schweiz) AG, CH
IZI
May 3, 2018K180019CAAS Workstation
Pie Medical Imaging BV, NL
IZI
Jul 24, 2017K162991YELLOW 560 Fluorescence Module
Carl Zeiss Meditec, AG, DE
IZI
Jul 5, 2017K170239Leica FL560
Leica Microsystems (Schweiz) AG, CH
IZI
Mar 11, 2016K151780CAAS Workstation
Pie Medical Imaging BV, NL
IZI
Aug 19, 2014K141136LEICA FL800
Leica Biosystems Richmond
IZI
Mar 27, 2014K133719PDE-NEO
Hamamatsu Photonics K.K.
IZI
Mar 25, 2014K133993CAAS WORKSTATION
Pie Medical Imaging, NL
IZI
Jan 31, 2014K130003XIRALITE FLOURESCENCE IMAGING SYSTEM X4
Mivenion GmbH, DE
IZI
May 21, 2013K130842ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES
Philips Medical Systems Nederland B.V., NL
IZI
Mar 2, 2012K113594C-THV SYSTEM
Paieon, Inc., IL
IZI
Dec 13, 2011K113034GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
GE Healthcare
IZI
Jul 26, 2011K111209INTEGRATED INNOVA - S5I SYSTEM OPTION
GE Healthcare, FR
IZI
May 27, 2011K110256THE IC-PRO SYSTEM
Paieon, Inc., IL
IZI
Feb 4, 2011K100371SPY INTRA-OPERATIVE IMAGING SYSTEM
Novadaq Technologies, Inc., CA
IZI
May 21, 2010K100849SYNC-RX SYSTEM, MODEL AS00010
Sync-Rx, Ltd.
IZI
Mar 3, 2010K100468ZEISS INFRARED 800 WITH FLOW 800 OPTION
Carl Zeiss Surgical GmbH
IZI
Jun 18, 2009K090745ARTIS ZEE / ZEEGOS WITH SW VC14
Siemens Medical Solutions USA, Inc.
IZI
Feb 17, 2009K083745THE IC-PRO SYSTEM, MODEL VERSION 3.2
Paieon, Inc., IL
IZI
Nov 18, 2008K082907IC-PRO SYSTEM, VERSION 3.1.0.4
Paieon, Inc., IL
IZI
Sep 9, 2008K073328CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA
Paieon, Inc., IL
IZI
May 9, 2008K080612LEICA FL800
Leica Microsystems (Schweiz) AG
IZI
Feb 11, 2008K073290ARTIS ZEE AND ZEEGO
Siemens Medical Solutions USA, Inc.
IZI
Jan 10, 2008K073130SPY FLUORESCENT IMAGING SYSTEM
Novadaq Technologies, Inc., CA
IZI
Jan 10, 2008K073088SPY FLUORESCENT IMAGING SYSTEM
Novadaq Technologies, Inc., CA
IZI
Nov 9, 2007K071619SPY FLUORESCENT IMAGING SYSTEM
Novadaq Technologies, Inc., CA
IZI
Oct 10, 2007K072591CARDIOP-B SYSTEM, VERSION 2.1
Paieon, Inc., IL
IZI
Sep 7, 2007K072222SPY FLUORESCENT IMAGING SYSTEM
Novadaq Technologies, Inc., CA
IZI
Aug 31, 2007K072006DAR-9400F
Shimadzu Corp.
IZI
Jul 5, 2007K071717GE OEC ALTITUDE
Shimadzu Corp., JP
IZI
May 10, 2007K071037SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000
Novadaq Technologies, Inc., CA
IZI
Jan 12, 2007K063345SPY IMAGING SYSTEM
Novadaq Technologies, Inc., CA
IZI
Oct 5, 2006K062360BRANSIST SAFIRE
Shimadzu Corp.
IZI
Sep 20, 2006K061871LEICA MODEL FL800
Leica Microsystems, Inc.
IZI
May 3, 2006K060867SPY INTRAOPERATIVE IMAGING SYSTEM
Novadaq Technologies, Inc., CA
IZI
Apr 4, 2006K060749XPERCT
Philips Medical Systems North America Co.
IZI

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