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IC-Flow Imaging System 2.0

by Diagnostic Green GmbH EUDAMED510(k)

Active European Union and United States

510(k) K243645

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK243645 Date22 Sep 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
IZI
Device Class
Class II
Regulation
21 CFR Part 892.1600
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IC-Flow Imaging System 2.0 is a handheld near-infrared (NIR) imaging device designed for fluorescence angiography. It visualizes and records tissue fluorescence when used with Indocyanine Green (ICG), enabling real-time assessment of blood flow, tissue perfusion, and lymphatic system dynamics in clinical settings.

This system is portable, compact, and intended for use in radiology procedures. It is supplied as a reusable medical device and has been authorized under FDA 510(k) clearance (K243645) and MDR compliance. The device operates within Class II regulatory classification and is intended for adult and pediatric patients aged one month and older.

Other devices from Diagnostic Green GmbH

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical scenarios is the IC-Flow Imaging System 2.0 designed to support with its fluorescence angiography capabilities?

    The IC-Flow Imaging System 2.0 is designed to visualize and record tissue fluorescence using Indocyanine Green (ICG), enabling real-time assessment of blood flow, tissue perfusion, and lymphatic system dynamics. This makes it particularly useful in radiology procedures where evaluating vascular health, perfusion defects, or lymphatic function is critical, such as in plastic surgery, dermatology, or vascular studies for adult and pediatric patients aged one month and older.

  • Is the IC-Flow Imaging System 2.0 a single-use or reusable device, and what does this mean for maintenance?

    The IC-Flow Imaging System 2.0 is explicitly described as a reusable medical device. This means it is designed for repeated use after proper cleaning, disinfection, and maintenance according to manufacturer guidelines. Reusability can reduce costs and waste but requires adherence to strict protocols to ensure sterility and functionality between uses.

  • What regulatory pathways has the IC-Flow Imaging System 2.0 followed, and what does this imply for its use in clinical settings?

    The device has been authorized under FDA 510(k) clearance (K243645) and MDR compliance, classifying it as a Class II medical device. This implies it has undergone rigorous review by regulatory bodies to ensure safety and effectiveness for its intended use in fluorescence angiography. Clinicians can rely on its compliance with these standards, though local regulations may still apply depending on the country of use.

  • How portable is the IC-Flow Imaging System 2.0, and what are its intended clinical environments?

    The IC-Flow Imaging System 2.0 is described as portable and compact, making it suitable for use in various clinical settings beyond fixed radiology departments. While primarily intended for radiology procedures, its design suggests flexibility for use in operating rooms, outpatient clinics, or other mobile diagnostic environments where real-time imaging of blood flow or perfusion is needed.

  • Does the IC-Flow Imaging System 2.0 require any specific consumables or additional agents for operation?

    Yes, the system relies on Indocyanine Green (ICG) as the fluorescent dye for imaging. ICG is injected into the patient to visualize blood flow, tissue perfusion, and lymphatic dynamics. The device itself is reusable, but the effectiveness of its imaging depends on the proper administration and compatibility of ICG with the patient’s physiology.