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510(k) K121076

ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE by Toshiba America Medical Systems, In.C — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2012
Date Received
April 9, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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  • K123097 — DOSE TRACKING SYSTEM MODEL XIDF-DTS801 (February 13, 2013)
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  • K122842 — RADREX-I, SW V4.00 MODEL DRAD-3000E (October 9, 2012)
  • K122109 — AQUILION ONE VISION, V4.90 (September 21, 2012)
  • K112989 — AQUILION CXL (April 10, 2012)

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