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 System, Image Processing, Radiological
510(k) Number K212421
Device Name ADAS 3D
Applicant
Adas3D Medical S.L.
Paris 179, 2-2
Barcelona,  ES 08036
Applicant Contact Antonio Riu
Correspondent
Adas3D Medical S.L.
Paris 179, 2-2
Barcelona,  ES 08036
Correspondent Contact Antonio Riu
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/04/2021
Decision Date 09/03/2021
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
-
-