FDA 510(k)

IC-Flow Imaging System 2.0

K-Number: K243645 · 2025-09-22

Decision Date2025-09-22

Product CodeIZI

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IC-Flow Imaging System 2.0 is a medical device manufactured by Diagnostic Green GmbH. It received FDA 510(k) clearance on 2025-09-22 under approval 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. It is manufactured by Diagnostic Green GmbH. The 510(k) number is K243645.

When was IC-Flow Imaging System 2.0 approved by the FDA?

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

What company makes IC-Flow Imaging System 2.0?

IC-Flow Imaging System 2.0 is manufactured by Diagnostic Green GmbH.

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.

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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.