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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
CASIS Cardiac Simulation & Imaging Software
7 impasse des Boussenots
Quetigny,  FR 21800
Applicant Contact Jean-Joseph Christophe
Gloster Biomedical International
577 N.Hope Ave, Suite 101
Santa Barbara,  CA  93110
Correspondent Contact Catherine Gloster
Regulation Number892.2050
Classification Product Code
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