• 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 automated radiological image processing software
510(k) Number K212466
Device Name LVivo Seamless
DiA Imaging Analysis Ltd
77 Haenergia Street
Beer-Sheva,  IL 8470912
Applicant Contact Michal Yaacobi
Medicsense USA
291 Hillside Avenue
Somerset,  MA  02726
Correspondent Contact George Hattub
Regulation Number892.2050
Classification Product Code
Date Received08/06/2021
Decision Date 12/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No