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510(k) K123576

IMR SOFTWARE APPLICATION by Philips Healthcare (Cleveland) — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2013
Date Received
November 20, 2012
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)

  • K133674 — PHILIPS IQON SPECTRAL CT (November 21, 2014)
  • K131773 — BRILLIANCE ICT (September 24, 2013)
  • K123599 — INGENUITY DIGITAL PET/CT (July 12, 2013)
  • K113483 — ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION (September 26, 2012)
  • K103483 — INGENUITY TF PET/MR (November 23, 2011)

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