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510(k) K093044

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

K093044 is an FDA 510(k) premarket notification submitted by Hitachi Medical Systems America, Inc. for the device "OASIS MRI SYSTEM". The FDA issued a decision of Substantially Equivalent on March 16, 2010. The device falls under product code LNI (System, Nuclear Magnetic Resonance Spectroscopic), a Class II device regulated under 21 CFR 892.1000. Hitachi Medical Systems America, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Hitachi Medical Systems America, Inc.

  • K163528 — HITACHI Supria Whole-body X-ray CT System Phase 3 (March 3, 2017)
  • K162079 — TRILLIUM Oval Head Coil 32 (September 16, 2016)
  • K161748 — SUPRIA w/guideShot Option (August 17, 2016)
  • K160152 — Trillium Oval V 5.1 MRI System (May 20, 2016)
  • K153547 — ECHELON Oval V 5.1 MRI System (March 31, 2016)
  • K150595 — SCENARIA Phase 3 Whole-body X-ray CT System (October 30, 2015)
  • K150565 — Supria Whole-body X-ray CT System (September 30, 2015)
  • K151015 — ECHELON Oval V 5.0 MRI System (July 29, 2015)
  • K143537 — Sirius Starmobile tiara (March 6, 2015)
  • K142734 — TRILLIUM Oval MR System (March 2, 2015)

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)

FDA data resources