Biograph Vision.X and Biograph Vision.X Edge— 510(k) K231833
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K231833 for Biograph Vision.X and Biograph Vision.X Edge, Substantially Equivalent on 2023-07-13. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hoffman Estates, IL, US
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