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 K202212
Device Name TruPlan
Applicant
Circle Cardiovascular Imaging Inc.
Suite 1100-800 5th Ave SW
Calgary,  CA T2P 3T6
Applicant Contact Shirantha Samarappuli
Correspondent
Circle Cardiovascular Imaging Inc.
Suite 1100-800 5th Ave SW
Calgary,  CA T2P 3T6
Correspondent Contact Shirantha Samarappuli
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/06/2020
Decision Date 02/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-