Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT— 510(k) K162736
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K162736 for Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT, Substantially Equivalent on 2016-10-25. 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
- Traditional
- Location
- Knoxville, TN, US
Recent devices under product code KPS
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