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 automated radiological image processing software
510(k) Number K230913
Device Name ANDI
Applicant
Imeka Solutions, Inc.
195, Belvedere Nord
#201
Sherbrooke,  CA J1H 4A7
Applicant Contact Valerie Lacroix
Correspondent
Imeka Solutions, Inc.
195, Belvedere Nord
#201
Sherbrooke,  CA J1H 4A7
Correspondent Contact Valerie Lacroix
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received03/31/2023
Decision Date 07/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-