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 K211222
Device Name qER-Quant
Applicant
Qure.ai Technologies
Level 7, Commerz II, International Business park, Oberoi
Garden City, Goregaon(E)
Mumbai,  IN 400063
Applicant Contact Pooja Rao
Correspondent
Qure.ai
Level 7, Commerz II, International Business park, Oberoi
Garden City, Goregaon(E)
Mumbai,  IN 400063
Correspondent Contact Pooja Rao
Regulation Number892.2050
Classification Product Code
QIH  
Date Received04/23/2021
Decision Date 07/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-