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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 K241879
Device Name vRad Viewer
Applicant
Virtual Radiologic Corporation
11995 Singletree Ln.
Eden Prairie,  MN  55344
Applicant Contact Wade Steigauf
Correspondent
Proxima Clinical Research
2450 Holcombe Blvd.
Houston,  TX  77021
Correspondent Contact Ellie Reynolds
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/28/2024
Decision Date 07/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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