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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 K161559
Device Name Kuvia3D
Applicant
4qimaging, LLC Dba Qmetrics
1250 Pittsford-Victor Rd.,
Suite 110, Bldg.200
Pittsford,  NY  14534
Applicant Contact EDWARD SCHREYER
Correspondent
4qimaging, LLC Dba Qmetrics
1250 Pittsford-Victor Rd.,
Suite 110, Bldg.200
Pittsford,  NY  14534
Correspondent Contact EDWARD SCHREYER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/06/2016
Decision Date 06/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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