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FDA 510(k) Application Details - K170716
Device Classification Name
System, X-Ray, Tomography, Computed
More FDA Info for this Device
510(K) Number
K170716
Device Name
System, X-Ray, Tomography, Computed
Applicant
Philips Ultrasound Inc.
3000 Minuteman Road
Andover, MA 01810 US
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Contact
Peng Cui
Other 510(k) Applications for this Contact
Regulation Number
892.1750
More FDA Info for this Regulation Number
Classification Product Code
JAK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/09/2017
Decision Date
04/21/2017
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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