AIAS Cephalon— 510(k) K252214

Substantially Equivalent

Metamorphosis GmbH

FDA 510(k) clearance K252214 for AIAS Cephalon, Substantially Equivalent on 2025-10-07. Applicant: Metamorphosis GmbH. Device class: 2.

Clearance details

Applicant: Metamorphosis GmbH
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-07-15
Decision date: 2025-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paderborn, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.