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 K192973
Device Name densitas densityai
Applicant
Densitas, Inc.
#66, 1344 Summer Street
Halifax,  CA B3H0A8
Applicant Contact Mo Abdolell
Correspondent
Densitas Inc.
#66, 1344 Summer Street
Halifax,  CA B3H0A8
Correspondent Contact Alex Morris
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/24/2019
Decision Date 02/19/2020
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
-
-