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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 K120062
Device Name DRX-REVOLUTION MOBILE X-RAY SYSTEM
Applicant
CARESTREAM HEALTH, INC.
12921 W Washington Blvd
Los Angeles,  CA  90066
Applicant Contact CAROLYN WAGNER
Correspondent
CARESTREAM HEALTH, INC.
12921 W Washington Blvd
Los Angeles,  CA  90066
Correspondent Contact CAROLYN WAGNER
Regulation Number892.1720
Classification Product Code
IZL  
Date Received01/09/2012
Decision Date 04/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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