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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K163624
Device Name Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
Applicant
FUJIFILM Medical Systems U.S.A., Inc.
419 West Avenue
Stamford,  CT  06902
Applicant Contact Dharaben Desai
Correspondent
FUJIFILM Medical Systems U.S.A., Inc.
419 West Avenue
Stamford,  CT  06902
Correspondent Contact Dharaben Desai
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/22/2016
Decision Date 06/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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