K260714
- 510(k) number
- K260714
- Device name
- MammoScreen® (5)
- Applicant
- Therapixel FR
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2026-06-26
- Date received
- 2026-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K260714.pdf
Official FDA record: K260714
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.