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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 K123082
Device Name MOBILECT VIEWER
Applicant
NEPHOSITY, INC.
615 GRANT AVENUE 3F
SAN FRANCISCO,  CA  94108
Applicant Contact MICHAEL PAN
Correspondent
NEPHOSITY, INC.
615 GRANT AVENUE 3F
SAN FRANCISCO,  CA  94108
Correspondent Contact MICHAEL PAN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/01/2012
Decision Date 05/16/2013
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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