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 Gastrointesinal Lesion Software Detection System
510(k) Number K223473
Device Name ME-APDS™; MAGENTIQ-COLO™
Applicant
Magentiq Eye LTD
6 Ben Gurion Blvd.
Haifa,  IL 3541416
Applicant Contact Dror Zur
Correspondent
Hogan Lovells US LLP
Columbia Square, 555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number876.1520
Classification Product Code
QNP  
Date Received11/17/2022
Decision Date 07/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-