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 Detection/Diagnosis Software For Lesions Suspicious For Cancer
510(k) Number K240697
Device Name See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
Applicant
See-Mode Technologies Pte. Ltd.
32 Carpenter Street, #03-01
Singapore,  SG 059911
Applicant Contact Sadaf Monajemi
Correspondent
See-Mode Technologies Pte. Ltd.
32 Carpenter Street, #03-01
Singapore,  SG 059911
Correspondent Contact Sadaf Monajemi
Classification Product Code
QDQ  
Subsequent Product Code
QIH  
Date Received03/14/2024
Decision Date 09/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-