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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 the device name listed in this FDA 510(k) record. The listed applicant is Metamorphosis GmbH. It received FDA 510(k) clearance on 2025-10-07 under 510(k) 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. The listed applicant is Metamorphosis GmbH. The 510(k) number is K252214.

When did AIAS Cephalon receive FDA 510(k) clearance?

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

Who is the listed applicant for AIAS Cephalon?

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

What is the FDA product code for AIAS Cephalon?

The FDA product code for AIAS Cephalon is QIH.

Related Devices (Code: QIH)

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.

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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.

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