IZI
SPY FLUORESCENT IMAGING SYSTEM
- Advisory panel
- Radiology
- Total cleared
- 197
Adverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code IZI
1–100 of 197- K243645 — IC-Flow Imaging System 2.0
- K243077 — Affirm 800
- K231986 — Modus IR
- K234090 — EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
- K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
- K230727 — SPY Portable Handheld Imaging (SPY-PHI) System
- K222240 — EXPLORER AIR® II
- K214097 — Explorer Air II
- K202391 — DIR 800
- K192761 — Asimov-MKS Imaging System
- K190772 — SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
- K182907 — SPY Elite Intraoperative Perfusion Assessment System
- K181537 — GLOW800
- K180019 — CAAS Workstation
- K162991 — YELLOW 560 Fluorescence Module
- K170239 — Leica FL560
- K151780 — CAAS Workstation
- K141136 — LEICA FL800
- K133719 — PDE-NEO
- K133993 — CAAS WORKSTATION
- K130003 — XIRALITE FLOURESCENCE IMAGING SYSTEM X4
- K130842 — ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES
- K113594 — C-THV SYSTEM
- K113034 — GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
- K111209 — INTEGRATED INNOVA - S5I SYSTEM OPTION
- K110256 — THE IC-PRO SYSTEM
- K100371 — SPY INTRA-OPERATIVE IMAGING SYSTEM
- K100849 — SYNC-RX SYSTEM, MODEL AS00010
- K100468 — ZEISS INFRARED 800 WITH FLOW 800 OPTION
- K090745 — ARTIS ZEE / ZEEGOS WITH SW VC14
- K083745 — THE IC-PRO SYSTEM, MODEL VERSION 3.2
- K082907 — IC-PRO SYSTEM, VERSION 3.1.0.4
- K073328 — CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA
- K080612 — LEICA FL800
- K073290 — ARTIS ZEE AND ZEEGO
- K073088 — SPY FLUORESCENT IMAGING SYSTEM
- K073130 — SPY FLUORESCENT IMAGING SYSTEM
- K071619 — SPY FLUORESCENT IMAGING SYSTEM
- K072591 — CARDIOP-B SYSTEM, VERSION 2.1
- K072222 — SPY FLUORESCENT IMAGING SYSTEM
- K072006 — DAR-9400F
- K071717 — GE OEC ALTITUDE
- K071037 — SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000
- K063345 — SPY IMAGING SYSTEM
- K062360 — BRANSIST SAFIRE
- K061871 — LEICA MODEL FL800
- K060867 — SPY INTRAOPERATIVE IMAGING SYSTEM
- K060749 — XPERCT
- K052500 — DAR-8000F
- K052076 — DAR-8000I
- K052039 — GE OEC ALTITUDE
- K042961 — SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000
- K042646 — DYNACT
- K041949 — ALLURA XPER FD10
- K041027 — DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D
- K030139 — THE CARDIOP-B SYSTEM
- K032443 — DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE
- K033184 — LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400
- K031333 — PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
- K023970 — QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS
- K023441 — PHILIPS MULTIDIAGNOST ELEVA
- K010721 — AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
- K010391 — ATLAS MULTI-PURPOSE DSA SYSTEM
- K002840 — MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM
- K993947 — KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY
- K993763 — QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)
- K993765 — QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)
- K991922 — DIGITAL IMAGING SYSTEM (BSR)
- K991231 — HITACHI VERSIFLEX
- K984545 — RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS
- K983877 — PHILIPS INTEGRIS 3D RA OPTION
- K982203 — CAAS II LVA BIPLANE OPTION
- K974679 — THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM
- K974367 — ADVANTX LCN, ADVANTX LCLP
- K973270 — LEG'MAP OPTION
- K973482 — PHILIPS INTEGRIS V5000 AND BV5000
- K972655 — CONTROL SYRINGE
- K973368 — STRAIT'MAP OPTION
- K972229 — IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM
- K973342 — DAR-3000B
- K971176 — VIEW ARCHIVING STATION
- K971181 — THE MIDVIEW-MEDCON'S DICOM VIEWER
- K971489 — RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4
- K972136 — TV MONITOR (P12/17)
- K971365 — PHILIPS INTEGRIS H5000
- K970738 — KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT
- K970525 — STATNET
- K955179 — CONTRAST MEDIA SET
- K961451 — DICOMNET
- K955519 — ANALYTICAL REVIEW STATION
- K960575 — ADVANTX LCV+
- K954581 — ARC SERIES
- K955395 — DAR-2400-15B/30B
- K945400 — HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100
- K954309 — ANGIOREX
- K953563 — VANGUARD XR-350 CINEANGIOGRAM PROJECTOR
- K952704 — PHILIPS EASYVISION
- K945540 — CAAS II
- K946378 — BCM 400CP
- K945449 — UNICATH LLU ANGIOGRAPHIC SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.