AI-Rad Companion Prostate MR— 510(k) K193283
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K193283 for AI-Rad Companion Prostate MR, Substantially Equivalent on 2020-07-30. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- 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
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