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 automated radiological image processing software
510(k) Number K211611
Device Name QIR Suite
Applicant
CASIS Cardiac Simulation & Imaging Software
7 impasse des Boussenots
Quetigny,  FR 21800
Applicant Contact Jean-Joseph Christophe
Correspondent
Gloster Biomedical International
577 N.Hope Ave, Suite 101
Santa Barbara,  CA  93110
Correspondent Contact Catherine Gloster
Regulation Number892.2050
Classification Product Code
QIH  
Date Received05/25/2021
Decision Date 09/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-