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FDA 510(k)

AIAS Cephalon

K-Number: K252214 · 2025-10-07

ApplicantMetamorphosis GmbH
Decision Date2025-10-07
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AIAS Cephalon is a medical device manufactured by Metamorphosis GmbH. It received FDA 510(k) clearance on 2025-10-07 under approval number K252214. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIAS Cephalon?

AIAS Cephalon is a medical device that received FDA 510(k) clearance on 2025-10-07. It is manufactured by Metamorphosis GmbH. The 510(k) number is K252214.

When was AIAS Cephalon approved by the FDA?

AIAS Cephalon received FDA 510(k) clearance on 2025-10-07, under approval number K252214.

What company makes AIAS Cephalon?

AIAS Cephalon is manufactured by Metamorphosis GmbH.

What is the FDA product code for AIAS Cephalon?

The FDA product code for AIAS Cephalon is QIH.

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Official Source

View on FDA Database →

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

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