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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K170858
Device Name FDR AQRO (DR-XD 1000)
Applicant
Fujifilm Medical Systems U.S.A, Inc.
419 W. Ave.
Stamford,  CT  06902
Applicant Contact Peter Altman
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
419 W. Ave.
Stamford,  CT  06902
Correspondent Contact Peter Altman
Regulation Number892.1720
Classification Product Code
IZL  
Date Received03/22/2017
Decision Date 04/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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