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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 K183593
Device Name Lung Vision System
Applicant
Body Vision Medical Ltd.
34 Sokolov St.
Ramat Hasharon,  IL
Applicant Contact Dorian Averbuch
Correspondent
Body Vision Medical Ltd. % ProMedic, LLC
131 Bay Point Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/21/2018
Decision Date 04/18/2019
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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