K251022
- 510(k) number
- K251022
- Device name
- 3D-SHAPER
- Applicant
- 3D-Shaper Medical S.L ES
- Product code
- KGI — Densitometer, Bone
- Decision date
- 2025-09-05
- Date received
- 2025-04-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251022.pdf
Official FDA record: K251022
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.