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FDA 510(k) Application Details - K192531
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K192531
Device Name
System, Image Processing, Radiological
Applicant
Qynapse
67 rue Saint Jacques
Paris 75005 FR
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Contact
Olivier Courreges
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
09/16/2019
Decision Date
12/13/2019
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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