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FDA 510(k) Application Details - K173467
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K173467
Device Name
System, Image Processing, Radiological
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
5684 PC Best
Best Noord-Brabant 5684 PC NL
Other 510(k) Applications for this Company
Contact
Yoram Levy
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
11/08/2017
Decision Date
12/12/2017
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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