FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II— 510(k) K013218
Substantially EquivalentFujifilm Medical System U.S.A., Inc.
FDA 510(k) clearance K013218 for FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II, Substantially Equivalent on 2001-12-20. 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
- Abbreviated
- Location
- Stamford, CT, US
Recent devices under product code MQB
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