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510(k) K170086

Pinnacle Radiation Therapy Planning System by Philips Medical Systems (Cleveland), Inc. — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2017
Date Received
January 10, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Philips Medical Systems (Cleveland), Inc.

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  • K163711 — IQon Spectral CT (April 5, 2017)
  • K160743 — Philips Ingenuity CT (August 8, 2016)
  • K153444 — Philips Multislice CT System with Low Dose CT Lung Cancer (April 8, 2016)
  • K130992 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (June 14, 2013)
  • K111336 — EBW NM 2.0 (May 24, 2011)
  • K111024 — JETPACK 2.0 (April 21, 2011)
  • K092747 — PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL (October 9, 2009)

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