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 Automated Radiological Image Processing Software
510(k) Number K252665
Device Name brAIn™ Shoulder Positioning
Applicant
Avatar Medical
11 Rue De Lourmel
Paris,  FR 75015
Applicant Contact Adeline Francois
Correspondent
Avatar Medical
11 Rue De Lourmel
Paris,  FR 75015
Correspondent Contact Adeline Francois
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/25/2025
Decision Date 10/20/2025
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
-
-