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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 K132586
Device Name PAXERAPACS
Applicant
Paxeramed
2001 E. Oak Shores Dr.
Aubrey,  TX  76227
Applicant Contact CARL ALLETTO
Correspondent
Paxeramed
2001 E. Oak Shores Dr.
Aubrey,  TX  76227
Correspondent Contact CARL ALLETTO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/16/2013
Decision Date 10/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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