K252214
- 510(k) number
- K252214
- Device name
- AIAS Cephalon
- Applicant
- Metamorphosis GmbH DE
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-10-07
- Date received
- 2025-07-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K252214.pdf
Official FDA record: K252214
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.