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510(k) K131822

ULTRAEXTEND USWS-900A V2.1 AND V3.1 by Toshiba America Medical Systems, In.C — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2013
Date Received
June 20, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Toshiba America Medical Systems, In.C

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  • K132106 — INFINIX ANGIO WORKSTATION W/DTS SOFTWARE (November 12, 2013)
  • K123097 — DOSE TRACKING SYSTEM MODEL XIDF-DTS801 (February 13, 2013)
  • K122613 — VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US (December 13, 2012)
  • K122842 — RADREX-I, SW V4.00 MODEL DRAD-3000E (October 9, 2012)
  • K121076 — ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE (October 9, 2012)
  • K122109 — AQUILION ONE VISION, V4.90 (September 21, 2012)
  • K112989 — AQUILION CXL (April 10, 2012)

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