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 Densitometer, Bone
510(k) Number K140342
Device Name QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT
Applicant
Mindways Software, Inc.
3001 S Lamar Blvd. Suite 302
Austin,  TX  78704
Applicant Contact KEENAN BROWN
Correspondent
Mindways Software, Inc.
3001 S Lamar Blvd. Suite 302
Austin,  TX  78704
Correspondent Contact KEENAN BROWN
Regulation Number892.1170
Classification Product Code
KGI  
Date Received02/11/2014
Decision Date 08/29/2014
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
-
-