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510(k) K172406

Ingenuity TF by Philips Medical Systems (Cleveland), Inc. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2017
Date Received
August 9, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

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

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  • K170086 — Pinnacle Radiation Therapy Planning System (February 9, 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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