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510(k) K071506

ECHELON SPECTROSCOPY PACKAGE by Hitachi Medical Systems America, Inc. — Product Code LNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2007
Date Received
June 1, 2007
Clearance Type
Abbreviated
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.

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  • K150595 — SCENARIA Phase 3 Whole-body X-ray CT System (October 30, 2015)
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  • 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)

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  • 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)