WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR— 510(k) K103596
Substantially EquivalentFujifilm Medical Systems U.S.A, Inc.
FDA 510(k) clearance K103596 for WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR, Substantially Equivalent on 2011-03-29. 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
- Special
- Location
- Stamford, CT, US
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