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510(k) K970005

GYREX 2T-PRESTIGE by Elscint, Inc. — Product Code LNI

K970005 is an FDA 510(k) premarket notification submitted by Elscint, Inc. for the device "GYREX 2T-PRESTIGE". The FDA issued a decision of Substantially Equivalent on March 28, 1997. The device falls under product code LNI (System, Nuclear Magnetic Resonance Spectroscopic), a Class II device regulated under 21 CFR 892.1000. Elscint, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1997
Date Received
January 2, 1997
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 Elscint, Inc.

  • K983313 — ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY (December 11, 1998)
  • K982060 — VOLUMAX CT IMAGING SYSTEM (September 2, 1998)
  • K974344 — CT SCOPE (June 3, 1998)
  • K980306 — GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP (April 2, 1998)
  • K974614 — GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG (March 4, 1998)
  • K972592 — 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) (September 15, 1997)
  • K970680 — GLORY (June 20, 1997)
  • K965044 — GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326 (June 16, 1997)
  • K970980 — CARDIAC SCORING FOR CT SCANNERS (May 29, 1997)
  • K964583 — XRT-7.0 (January 17, 1997)

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)
  • 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)
  • K930265 — HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT (April 25, 1995)

FDA data resources