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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 K163622
Device Name Lung Vision
Applicant
Bodyvision Medical , Ltd.
34 Sokolov St.
Ramat Hasharon,  IL
Applicant Contact DORIAN AVERBUCH
Correspondent
ProMedic, LLC
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/22/2016
Decision Date 05/11/2017
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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