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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 K151687
Device Name QuantorView
Applicant
3DISC AMERICAS
22560 GLENN DR STE 116
STERLING,  VA  20164
Applicant Contact SIGRID SMITT-JEPPESEN
Correspondent
KAMM & ASSOCIATES
8870 RAVELLO CT
NAPLES,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/23/2015
Decision Date 08/03/2015
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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