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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Predetermined Change
Control Plan Authorized		 No
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