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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K132799
Device Name CLARISO PACS
Applicant
CLARISO, INC.
111 MELANIE DRIVE
AUBREY,  TX  76227
Applicant Contact CARL ALLETTO
Correspondent
CLARISO, INC.
111 MELANIE DRIVE
AUBREY,  TX  76227
Correspondent Contact CARL ALLETTO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/06/2013
Decision Date 11/07/2013
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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