FDA.report

510(k) K243645

Device
IC-Flow™ Imaging System 2.0
Applicant
Diagnostic Green GmbH
510(k) number
K243645
Product code
IZI
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-22
Date received
2024-11-26
Regulation
892.1600
Classification name
System, X-Ray, Angiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Ann M Maloney
Address
Feldkirchener St. 7c 85551 Kirchheim B. München DE

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code IZI

510(k)DeviceApplicantDecision date
K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation2026-05-13
K243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)2025-06-27
K231986Modus IRSynaptive Medical, Inc.2024-03-25
K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH2024-03-20
K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, Inc.2023-06-20
K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)2023-06-05
K222240EXPLORER AIR® IISurgvision GmbH2023-02-28
K214097Explorer Air IISurgvision GmbH2022-02-25
K202391DIR 800Aesculap, Inc.2021-01-21
K192761Asimov-MKS Imaging SystemOnlume, Inc.2020-01-17
K190772SURGICAL MICROSCOPE SYSTEM ORBEYE with IROlympus Medical Systems Corp.2019-10-10
K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker)2019-01-23
K181537GLOW800Leica Microsystems (Schweiz) AG2018-09-07
K180019CAAS WorkstationPie Medical Imaging BV2018-05-03
K162991YELLOW 560 Fluorescence ModuleCarl Zeiss Meditec, AG2017-07-24