IZI · Class II · 21 CFR 892.1600

FDA Product Code IZI: System, X-ray, Angiographic

Leading manufacturers include Siemens Medical Solutions USA, Inc., Xre Corp. and Shimadzu Precision Instruments, Inc..

199
Total
199
Cleared
102d
Avg days
1978
Since
Stable submission activity - 4 submissions in the last 2 years
Review times increasing: avg 215d recently vs 100d historically

FDA 510(k) Cleared System, X-ray, Angiographic Devices (Product Code IZI)

199 devices
1–24 of 199
Cleared May 28, 2026
780 nm SPY Portable Handheld Imaging (SPY-PHI) System
K261037
Stryker Endoscopy
General & Plastic Surgery · 59d
Cleared May 13, 2026
SURGIMAGE SIM 1000H Fluorescence Imaging Platform
K253181
Surgimage Corporation
General & Plastic Surgery · 229d
Cleared Sep 22, 2025
IC-Flow™ Imaging System 2.0
K243645
Diagnostic Green GmbH
General & Plastic Surgery · 300d
Cleared Jun 27, 2025
Affirm 800
K243077
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
Neurology · 270d
Cleared Mar 25, 2024
Modus IR
K231986
Synaptive Medical, Inc.
Neurology · 264d
Cleared Mar 20, 2024
EXPLORER AIR® II (8001, 8002, 8003)
K234090
Surgvision GmbH
General & Plastic Surgery · 89d
Cleared Jun 20, 2023
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
K231075
Carl Zeiss Meditec, Inc.
General & Plastic Surgery · 67d
Cleared Jun 05, 2023
SPY Portable Handheld Imaging (SPY-PHI) System
K230727
Novadaq Technologies Ulc (A Part of Stryker)
General & Plastic Surgery · 81d
Cleared Feb 28, 2023
EXPLORER AIR® II
K222240
Surgvision GmbH
General & Plastic Surgery · 217d
Cleared Feb 25, 2022
Explorer Air II
K214097
Surgvision GmbH
General & Plastic Surgery · 59d
Cleared Jan 21, 2021
DIR 800
K202391
Aesculap, Inc.
Neurology · 153d
Cleared Jan 17, 2020
Asimov-MKS Imaging System
K192761
Onlume, Inc.
General & Plastic Surgery · 109d
Cleared Oct 10, 2019
SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
K190772
Olympus Medical Systems Corp.
Neurology · 198d
Cleared Jan 23, 2019
SPY Elite Intraoperative Perfusion Assessment System
K182907
Novadaq Technologies Ulc. (Now A Part of Stryker)
General & Plastic Surgery · 98d
Cleared Sep 07, 2018
GLOW800
K181537
Leica Microsystems (Schweiz) AG
Neurology · 88d
Cleared May 03, 2018
CAAS Workstation
K180019
Pie Medical Imaging BV
Radiology · 121d
Cleared Jul 24, 2017
YELLOW 560 Fluorescence Module
K162991
Carl Zeiss Meditec, AG
Radiology · 270d
Cleared Jul 05, 2017
Leica FL560
K170239
Leica Microsystems (Schweiz) AG
Radiology · 160d
Cleared Mar 11, 2016
CAAS Workstation
K151780
Pie Medical Imaging BV
Radiology · 254d
Cleared Aug 19, 2014
LEICA FL800
K141136
Leica Biosystems Richmond
Radiology · 110d
Cleared Mar 27, 2014
PDE-NEO
K133719
Hamamatsu Photonics K.K.
Radiology · 112d
Cleared Mar 25, 2014
CAAS WORKSTATION
K133993
Pie Medical Imaging
Radiology · 89d
Cleared Jan 31, 2014
XIRALITE FLOURESCENCE IMAGING SYSTEM X4
K130003
Mivenion GmbH
Radiology · 394d
Cleared May 21, 2013
ALLURA XPER FD OR TABLE SERIES
K130842
Philips Medical Systems Nederland B.V.
Radiology · 55d

About Product Code IZI - Regulatory Context

510(k) Submission Activity

199 total 510(k) submissions under product code IZI since 1978, with 199 receiving FDA clearance (average review time: 102 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA 510(k) Review Time - IZI Product Code

Recent submissions under IZI have taken an average of 215 days to reach a decision - up from 100 days historically. Manufacturers should account for longer review timelines in current project planning.

IZI devices are reviewed by the Radiology panel. Browse all Radiology devices →