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 Prioritization Software For Lesions
510(k) Number K233108
Device Name VinDr-Mammo
Applicant
VinBigData Joint Stock Company
Symphony Office Building, Chu Huy Man Street,
Vinhomes Riverside Ecological Urban Area
Ha Noi,  VN 100000
Applicant Contact Nguyet (Jun) Phan
Correspondent
VinBigData Joint Stock Company
Symphony Office Building, Chu Huy Man Street,
Vinhomes Riverside Ecological Urban Area
Ha Noi,  VN 100000
Correspondent Contact Nguyet (Jun) Phan
Regulation Number892.2080
Classification Product Code
QFM  
Date Received09/27/2023
Decision Date 05/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-