K251629
- 510(k) number
- K251629
- Device name
- UNiD Spine Analyzer
- Applicant
- Medicrea International S.A.S. (Medtronic) FR
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-08-07
- Date received
- 2025-05-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251629.pdf
Official FDA record: K251629
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.