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 K232410
Device Name SmartChest
Applicant
Milvue
29 Rue du Faubourg Saint Jacques
Paris,  FR 75014
Applicant Contact Oumaya Ibrahim
Correspondent
Cosm
45 Bartlett St.
San Francisco,  CA  94110
Correspondent Contact Rory Carrillo
Regulation Number892.2080
Classification Product Code
QFM  
Date Received08/10/2023
Decision Date 05/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-