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, x-ray, tomography, computed
510(k) Number K232392
Device Name CT Lung Ventilation Analysis Software (CT:V)
Applicant
4DMedical Limited
Level 7, 700 Swanston Street
Carlton,  AU 3053
Applicant Contact Nichole Murray
Correspondent
4DMedical Limited
Level 7, 700 Swanston Street
Carlton,  AU 3053
Correspondent Contact Nichole Murray
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/09/2023
Decision Date 11/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-