QP-Prostate® CAD— 510(k) K242683
Substantially EquivalentQuibim S.L.
FDA 510(k) clearance K242683 for QP-Prostate® CAD, Substantially Equivalent on 2025-03-18. Applicant: Quibim S.L.. Device class: 2.
Clearance details
- Applicant
- Quibim S.L.
- 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
- Traditional
- Location
- Valencia, ES
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