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510(k) K243645

IC-Flow™ Imaging System 2.0 by Diagnostic Green GmbH — Product Code IZI

K243645 is an FDA 510(k) premarket notification submitted by Diagnostic Green GmbH for the device "IC-Flow™ Imaging System 2.0". The FDA issued a decision of Substantially Equivalent on September 22, 2025. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2025
Date Received
November 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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  • K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (June 20, 2023)
  • K230727 — SPY Portable Handheld Imaging (SPY-PHI) System (June 5, 2023)
  • K222240 — EXPLORER AIR® II (February 28, 2023)
  • K214097 — Explorer Air II (February 25, 2022)
  • K202391 — DIR 800 (January 21, 2021)

FDA data resources