510(k) K153444

Philips Multislice CT System with Low Dose CT Lung Cancer by Philips Medical Systems (Cleveland), Inc. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2016
Date Received
November 27, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type