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510(k) K010129

EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 by Toshiba America Medical Systems, In.C — Product Code LNI

K010129 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3". The FDA issued a decision of Substantially Equivalent on April 5, 2001. The device falls under product code LNI (System, Nuclear Magnetic Resonance Spectroscopic), a Class II device regulated under 21 CFR 892.1000. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2001
Date Received
January 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Spectroscopic
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Toshiba America Medical Systems, In.C

  • K141472 — VANTAGE ELAN (September 19, 2014)
  • K133553 — KALARE (June 13, 2014)
  • K140729 — APLIO ARTIDA, V3.2 (May 23, 2014)
  • 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)
  • 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)

Other clearances for product code LNI

  • K093044 — OASIS MRI SYSTEM (March 16, 2010)
  • K071506 — ECHELON SPECTROSCOPY PACKAGE (June 28, 2007)
  • K011604 — PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI (August 22, 2001)
  • K003575 — MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM (January 17, 2001)
  • K991568 — MR SPECTROSCOPY PACKAGE (July 19, 1999)
  • K984167 — SAGE 7 (January 12, 1999)
  • K962627 — CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM (April 3, 1997)
  • K970005 — GYREX 2T-PRESTIGE (March 28, 1997)
  • K930265 — HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT (April 25, 1995)

FDA data resources