Transpara (2.1.0)— 510(k) K260898
Substantially EquivalentScreenpoint Medical B.V.
FDA 510(k) clearance K260898 for Transpara (2.1.0), Substantially Equivalent on 2026-08-14. Applicant: Screenpoint Medical B.V.. Device class: 2.
Summary
ScreenPoint Medical's Transpara, version 2.1.0, is filed under product code QDQ, radiological computer assisted detection/diagnosis software for lesions suspicious for cancer.
Class II, 21 CFR 892.2090. Radiology is both the classification panel and the review panel. It came in as a Special 510(k).
ScreenPoint filed from Nijmegen, Netherlands. The substantially equivalent decision came 149 calendar days after receipt (March 18 to August 14, 2026).
Clearance details
- Applicant
- Screenpoint Medical B.V.
- Product code
- Product code QDQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Nijmegen, NL
Recent devices under product code QDQ
view allMore clearances from Screenpoint Medical B.V.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.