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510(k) K152138

FDR D-EVO GL Flat Panel Detector System by Fujifilm Medical System U.S.A., Inc. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2015
Date Received
July 31, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K132188 — MAMMOGRAPHY VIEWER SMV658 (October 25, 2013)
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Other clearances for product code MQB

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  • K243171 — Yushan X-Ray Flat Panel Detector (December 19, 2024)
  • K241319 — SKR 3000 (November 21, 2024)