FLAT PANEL DETECTOR, MODEL FDR D-EVO— 510(k) K100762
Substantially EquivalentFujifilm Medical Systems U.S.A, Inc.
FDA 510(k) clearance K100762 for FLAT PANEL DETECTOR, MODEL FDR D-EVO, Substantially Equivalent on 2010-07-15. Applicant: Fujifilm Medical Systems U.S.A, Inc.. Device class: 2.
Clearance details
- Applicant
- Fujifilm Medical Systems 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
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