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 Analyzer, Medical Image
510(k) Number K231805
Device Name qXR-LN
Applicant
Qure.ai Technologies
Level 7, Commerz II, International Business Park
Oberoi Garden City, Goregaon(E)
Mumbai,  IN 400063
Applicant Contact Sri Anusha Matta
Correspondent
Qure.ai Technologies
Level 7, Commerz II, International Business Park
Oberoi Garden City, Goregaon(E)
Mumbai,  IN 400063
Correspondent Contact Sri Anusha Matta
Regulation Number892.2070
Classification Product Code
MYN  
Date Received06/20/2023
Decision Date 12/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-