K242171
- 510(k) number
- K242171
- Device name
- TechCare Trauma
- Applicant
- Milvue FR
- Product code
- QBS — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2025-01-17
- Date received
- 2024-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K242171.pdf
Official FDA record: K242171
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.