Home / 510(k) Clearances / K952674

510(k) K952674

TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA by Elscint, Inc. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1995
Date Received
June 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
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)
  • K970005 — GYREX 2T-PRESTIGE (March 28, 1997)

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