Home / 510(k) Clearances / K844189

510(k) K844189

LINEAR SCANNER PROBE ELSCINT LTD. TL-35 by Elscint, Inc. — Product Code IYP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1985
Date Received
October 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phantom, Anthropomorphic, Nuclear
Device Class
Class I
Regulation Number
892.1370
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)

Other clearances for product code IYP

  • K921878 — SCANMATE III (September 11, 1992)
  • K812893 — SUPERFLAB (December 8, 1981)