QIR Suite

Automated Radiological Image Processing Software

CASIS Cardiac Simulation & Imaging Software

The following data is part of a premarket notification filed by Casis Cardiac Simulation & Imaging Software with the FDA for Qir Suite.

Pre-market Notification Details

Device IDK211611
510k NumberK211611
Device Name:QIR Suite
ClassificationAutomated Radiological Image Processing Software
Applicant CASIS Cardiac Simulation & Imaging Software 7 Impasse Des Boussenots Quetigny,  FR 21800
ContactJean-Joseph Christophe
CorrespondentCatherine Gloster
Gloster Biomedical International 577 N.Hope Ave, Suite 101 Santa Barbara,  CA  93110
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-25
Decision Date2022-09-30

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