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, Nuclear Magnetic Resonance Imaging
510(k) Number K203451
Device Name TCL3 Motion Tracking System
Applicant
Tracinnovations Aps
World Trade Center Borupvang 3 Dk-2750
Ballerup,  DK
Applicant Contact Stefan Glimberg
Correspondent
Sheila Pickering PHD
2081 Longden Circle
Los Altos,  CA  94024
Correspondent Contact Sheila Pickering
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/23/2020
Decision Date 04/28/2021
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
-
-