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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 K151988
FOIA Releasable 510(k) K151988
Device Name Visible Patient Suite
Applicant
Visible Patient, Sas
1 Pl. De L'Hopital
Strasbourg,  FR 67091
Applicant Contact AUDE PETITJEAN
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JOHN J. SMITH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/17/2015
Decision Date 10/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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