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510(k) K122613

VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US by Toshiba America Medical Systems, In.C — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2012
Date Received
August 27, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
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)
  • K131822 — ULTRAEXTEND USWS-900A V2.1 AND V3.1 (July 23, 2013)
  • K123097 — DOSE TRACKING SYSTEM MODEL XIDF-DTS801 (February 13, 2013)
  • K121076 — ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE (October 9, 2012)
  • 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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