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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K243645
Device Name IC-Flow™ Imaging System 2.0
Applicant
Diagnostic Green GmbH
Feldkirchener St. 7c
85551
Kirchheim B. München,  DE
Applicant Contact Ann M Maloney
Correspondent
Jeff Yuen and Associates
1121 Military Cutoff Rd.
C 376
Wilmington,  NC  28405
Correspondent Contact Moj Eram
Regulation Number892.1600
Classification Product Code
IZI  
Date Received11/26/2024
Decision Date 09/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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