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 Radiological Computer-Assisted Triage And Notification Software
510(k) Number K242292
Device Name uAI Easy Triage ICH
Applicant
Shanghai United Imaging Intelligence Co., Ltd.
No. 701 Yunjin Road, Xuhui District
Shanghai,  CN 200232
Applicant Contact Zhao Xiaojing
Correspondent
MCRA Digital Health
803 7th Street NW, 3rd Floor
Washington,  DC  20001
Correspondent Contact Nima Akhlaghi
Regulation Number892.2080
Classification Product Code
QAS  
Date Received08/02/2024
Decision Date 09/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-