QFR (3.0)— 510(k) K243769
Substantially EquivalentQfr Solutions BV
FDA 510(k) clearance K243769 for QFR (3.0), Substantially Equivalent on 2025-04-04. Applicant: Qfr Solutions BV. Device class: 2.
Clearance details
- Applicant
- Qfr Solutions BV
- Product code
- Code QHA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1600
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leiden, NL
Recent devices under product code QHA
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