FDR D-EVO II FLAT PANEL DETECTOR SYSTEM— 510(k) K142003
Substantially EquivalentFujifilm Medical System U.S.A., Inc.
FDA 510(k) clearance K142003 for FDR D-EVO II FLAT PANEL DETECTOR SYSTEM, Substantially Equivalent on 2014-10-21. Applicant: Fujifilm Medical System U.S.A., Inc.. Device class: 2.
Clearance details
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
Recent devices under product code MQB
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