K260206
- 510(k) number
- K260206
- Device name
- SkeletonPlanner
- Applicant
- UPlanner B.V. - Presurgeo NL
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-07-15
- Date received
- 2026-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K260206.pdf
Official FDA record: K260206
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.