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510(k) K052345

ADVANTAGE SIM MD by Ge Healthcare — Product Code KPQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2005
Date Received
August 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Simulation, Radiation Therapy
Device Class
Class II
Regulation Number
892.5840
Review Panel
RA
Submission Type

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Other clearances for product code KPQ

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  • K052361 — SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM (October 24, 2005)
  • K033470 — SIMULIX EVOLUTION (February 4, 2004)
  • K033339 — ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (December 30, 2003)