FUJI FCR IMAGE PROCESSING UNIT IP-U515— 510(k) K942561
Substantially EquivalentFujifilm Medical System U.S.A., Inc.
FDA 510(k) clearance K942561 for FUJI FCR IMAGE PROCESSING UNIT IP-U515, Substantially Equivalent on 1994-12-23. Applicant: Fujifilm Medical System U.S.A., Inc.. Device class: 2.
Clearance details
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Product code
- Code IXK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1630
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
Recent devices under product code IXK
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