K243679
- 510(k) number
- K243679
- Device name
- MammoScreen® (4)
- Applicant
- Therapixel FR
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2025-07-03
- Date received
- 2024-11-29
- 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: K243679.pdf
Official FDA record: K243679
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.