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FDA 510(k) Application Details - K213998
Device Classification Name
More FDA Info for this Device
510(K) Number
K213998
Device Name
cvi42 Auto Imaging Software Application
Applicant
Circle Cardiovascular Imaging Inc
Suite 1100 - 800 5th Ave SW
Calgary T2P 3T6 CA
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Contact
Sydney Toutant
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Regulation Number
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Classification Product Code
QIH
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More FDA Info for this Product Code
Date Received
12/21/2021
Decision Date
07/28/2022
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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