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510(k) K113483

ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION by Philips Healthcare (Cleveland) — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2012
Date Received
November 23, 2011
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)

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  • K123576 — IMR SOFTWARE APPLICATION (June 7, 2013)
  • K103483 — INGENUITY TF PET/MR (November 23, 2011)

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