Biograph mMR with syngo MR E11P system software— 510(k) K163234
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K163234 for Biograph mMR with syngo MR E11P system software, Substantially Equivalent on 2017-02-28. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code OUO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
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