DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM— 510(k) K964069
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K964069 for DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM, Substantially Equivalent on 1997-05-08. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code IZH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1710
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Iselin, NJ, US
Recent devices under product code IZH
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