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FDA 510(k) Application Details - K181773
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K181773
Device Name
System, Image Processing, Radiological
Applicant
FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun 258-8538 JP
Other 510(k) Applications for this Company
Contact
Randy Vader
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
07/03/2018
Decision Date
09/25/2018
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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