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510(k) K160743

Philips Ingenuity CT by Philips Medical Systems (Cleveland), Inc. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2016
Date Received
March 17, 2016
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

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  • K130992 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (June 14, 2013)
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  • K111024 — JETPACK 2.0 (April 21, 2011)
  • K092747 — PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL (October 9, 2009)

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