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510(k) K150221

EPX-4440HD and EPX-4400HD with FICE by Fujifilm Medical System U.S.A., Inc. — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2015
Date Received
January 30, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

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  • K152138 — FDR D-EVO GL Flat Panel Detector System (November 5, 2015)
  • K142629 — EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes (May 14, 2015)
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  • K133976 — FUJIFILM ENDOSCOPIC CO2 REGULATOR (September 9, 2014)
  • K132188 — MAMMOGRAPHY VIEWER SMV658 (October 25, 2013)
  • K130542 — SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS (June 14, 2013)
  • K130383 — SYNAPSE 3D CARDIAC TOOLS (April 9, 2013)

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