AI-Rad Companion Brain MR— 510(k) K232305
Substantially EquivalentSiemens Medical Solutions U.S.A.
FDA 510(k) clearance K232305 for AI-Rad Companion Brain MR, Substantially Equivalent on 2023-10-23. Applicant: Siemens Medical Solutions U.S.A.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions U.S.A.
- 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
- Malvern, PA, US
Recent devices under product code QIH
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