FDR D-EVO GL Flat Panel Detector System— 510(k) K152138
Substantially EquivalentFujifilm Medical System U.S.A., Inc.
FDA 510(k) clearance K152138 for FDR D-EVO GL Flat Panel Detector System, Substantially Equivalent on 2015-11-05. 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
view allMore clearances from Fujifilm Medical System U.S.A., Inc.
view all- K163675 — Processor VP-7000, Light Source BL-7000
- K153206 — Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
- K151474 — Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
- K150221 — EPX-4440HD and EPX-4400HD with FICE
- K142629 — EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
Data sourced from openFDA. This site is unofficial and independent of the FDA.