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FDA 510(k)

IC-Flow™ Imaging System 2.0

K-Number: K243645 · 2025-09-22

ApplicantDiagnostic Green GmbH
Decision Date2025-09-22
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IC-Flow™ Imaging System 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Green GmbH. It received FDA 510(k) clearance on 2025-09-22 under 510(k) number K243645. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IC-Flow™ Imaging System 2.0?

IC-Flow™ Imaging System 2.0 is a medical device that received FDA 510(k) clearance on 2025-09-22. The listed applicant is Diagnostic Green GmbH. The 510(k) number is K243645.

When did IC-Flow™ Imaging System 2.0 receive FDA 510(k) clearance?

IC-Flow™ Imaging System 2.0 received FDA 510(k) clearance on 2025-09-22, under 510(k) number K243645.

Who is the listed applicant for IC-Flow™ Imaging System 2.0?

The FDA 510(k) record lists Diagnostic Green GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IC-Flow™ Imaging System 2.0?

The FDA product code for IC-Flow™ Imaging System 2.0 is IZI.

Related Devices (Code: IZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbHK231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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