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510(k) K093044

OASIS MRI SYSTEM by Hitachi Medical Systems America, Inc. — Product Code LNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2010
Date Received
September 30, 2009
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

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Other clearances for product code LNI

  • K071506 — ECHELON SPECTROSCOPY PACKAGE (June 28, 2007)
  • K011604 — PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI (August 22, 2001)
  • K010129 — EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 (April 5, 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)