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510(k) K133674

PHILIPS IQON SPECTRAL CT by Philips Healthcare (Cleveland) — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2014
Date Received
November 29, 2013
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

Other clearances by Philips Healthcare (Cleveland)

  • K131773 — BRILLIANCE ICT (September 24, 2013)
  • K123599 — INGENUITY DIGITAL PET/CT (July 12, 2013)
  • K123576 — IMR SOFTWARE APPLICATION (June 7, 2013)
  • K113483 — ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION (September 26, 2012)
  • K103483 — INGENUITY TF PET/MR (November 23, 2011)

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