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The Tracker / October 2025 / K252214

510(k) cleared

AIAS Cephalon

Metamorphosis GmbH · Oct 7, 2025 · K252214

FDA cleared the AIAS Cephalon from Metamorphosis GmbH on Oct 7, 2025 under K252214, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 15, 2025. The decision came 84 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Metamorphosis GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252214?

K252214 is the FDA 510(k) for AIAS Cephalon, submitted by Metamorphosis GmbH. FDA's decision date was Oct 7, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the AIAS Cephalon?

Metamorphosis GmbH, based in Paderborn, is the applicant of record for K252214.

How long did the K252214 review take?

FDA received the submission on Jul 15, 2025 and issued its decision on Oct 7, 2025, 84 days later.

← All decisions in October 2025