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FDA 510(k) Application Details - K173378
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K173378
Device Name
System, Image Processing, Radiological
Applicant
Siemens Healthcare GmbH
Henkestrasse 127
Erlangen 91052 DE
Other 510(k) Applications for this Company
Contact
Abhineet Johri
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
10/30/2017
Decision Date
11/20/2017
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
Y
Expedited Review
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