K243218
- 510(k) number
- K243218
- Device name
- TBS iNsight (V4)
- Applicant
- Medimaps Group SA CH
- Product code
- KGI — Densitometer, Bone
- Decision date
- 2025-01-17
- Date received
- 2024-10-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243218.pdf
Official FDA record: K243218
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.