Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-