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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 K162145
Device Name vRad PACS with Mammography
Applicant
Virtual Radiologic Corporation
11995 Singletree Lane, Suite 500
Eden Prairie,  MN  55344
Applicant Contact Melinda Sewell
Correspondent
Virtual Radiologic Corporation
11995 Singletree Lane, Suite 500
Eden Prairie,  MN  55344
Correspondent Contact Melinda Sewell
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/01/2016
Decision Date 10/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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