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FDA 510(k) Application Details - K211611
Device Classification Name
More FDA Info for this Device
510(K) Number
K211611
Device Name
QIR Suite
Applicant
CASIS Cardiac Simulation & Imaging Software
7 impasse des Boussenots
Quetigny 21800 FR
Other 510(k) Applications for this Company
Contact
Jean-Joseph Christophe
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/25/2021
Decision Date
09/30/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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