K261289
- 510(k) number
- K261289
- Device name
- UNiD Spine Analyzer (SW3002)
- Applicant
- Medicrea International S.A.S. (Medtronic) FR
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-05-15
- Date received
- 2026-04-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K261289.pdf
Official FDA record: K261289
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.