• 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 K173605
Device Name iQMR
Medic Vision - Imaging Solutions Ltd
3 Hayozma Street
Tirat Carmel,  IL 3903203
Applicant Contact Eyal Aharon
Dan Laor
6 Sireni
Haifa,  IL 3297206
Correspondent Contact Dan Laor
Regulation Number892.2050
Classification Product Code
Date Received11/21/2017
Decision Date 03/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No