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FDA 510(k) Application Details - K212005
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K212005
Device Name
System, Image Processing, Radiological
Applicant
MEDICREA International, Inc.
5389 Route de Strasbourg - Vancia
Rilleux La Pape 69140 FR
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Contact
David Ryan
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/28/2021
Decision Date
01/12/2022
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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