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 Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
510(k) Number K251071
Device Name Fetal EchoScan (v1.1)
Applicant
BrightHeart
7-11 boulevard Haussmann
Paris,  FR 75009
Applicant Contact Christophe Gardella
Correspondent
BrightHeart
7-11 boulevard Haussmann
Paris,  FR 75009
Correspondent Contact Christophe Gardella
Regulation Number892.2060
Classification Product Code
POK  
Date Received04/07/2025
Decision Date 05/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-