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510(k) K974614

GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 by Elscint, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1998
Date Received
December 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
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)
  • 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)
  • K970005 — GYREX 2T-PRESTIGE (March 28, 1997)
  • K964583 — XRT-7.0 (January 17, 1997)

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  • K252379 — AIR Recon DL (December 23, 2025)
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