Transpara Density 1.0.0— 510(k) K232096
Substantially EquivalentScreenpoint Medical B.V.
FDA 510(k) clearance K232096 for Transpara Density 1.0.0, Substantially Equivalent on 2023-12-11. Applicant: Screenpoint Medical B.V.. Device class: 2.
Clearance details
- Applicant
- Screenpoint Medical B.V.
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nijmegen, NL
Recent devices under product code QIH
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