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FDA 510(k) Application Details - K192475
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K192475
Device Name
System, Image Processing, Radiological
Applicant
Software Nemotec S.L.
Juan de la Cierva Street, 66
Arroyomolinos, Madrid 28939 ES
Other 510(k) Applications for this Company
Contact
Carlos Arias
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
09/10/2019
Decision Date
04/23/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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