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510(k) K131773

BRILLIANCE ICT by Philips Healthcare (Cleveland) — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2013
Date Received
June 17, 2013
Clearance Type
Special
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

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  • K113483 — ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION (September 26, 2012)
  • K103483 — INGENUITY TF PET/MR (November 23, 2011)

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