K260898
- 510(k) number
- K260898
- Device name
- Transpara (2.1.0)
- Applicant
- Screenpoint Medical B.V. NL
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2026-08-14
- Date received
- 2026-03-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K260898.pdf
Official FDA record: K260898
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.