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510(k) K130992

PINNACLE3 RADIATION THERAPY PLANNING SYSTEM by Philips Medical Systems (Cleveland), Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2013
Date Received
April 10, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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  • K160743 — Philips Ingenuity CT (August 8, 2016)
  • K153444 — Philips Multislice CT System with Low Dose CT Lung Cancer (April 8, 2016)
  • K111336 — EBW NM 2.0 (May 24, 2011)
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  • K092747 — PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL (October 9, 2009)

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