K241561
- 510(k) number
- K241561
- Device name
- MammoScreen BD
- Applicant
- Therapixel FR
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-10-02
- Date received
- 2024-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.9 MB · U.S. public domain
Also available from FDA: K241561.pdf
Official FDA record: K241561
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.