Transpara (2.1.0)— 510(k) K260898

Substantially Equivalent

Screenpoint 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.

Clearance details

Applicant
Screenpoint Medical B.V.
Product code
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
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