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 K253784
Device Name 3DICOM MD Cloud
Applicant
Singular Health Pty, Ltd.
E3/661 Newcastle St.
Leederville,  AU 6007
Applicant Contact Andre Marchezini Rocha
Correspondent
Singular Health Pty, Ltd.
E3/661 Newcastle St.
Leederville,  AU 6007
Correspondent Contact Andre Marchezini Rocha
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/26/2025
Decision Date 01/08/2026
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
-
-