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510(k) K844189

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

K844189 is an FDA 510(k) premarket notification submitted by Elscint, Inc. for the device "LINEAR SCANNER PROBE ELSCINT LTD. TL-35". The FDA issued a decision of Substantially Equivalent on February 25, 1985. The device falls under product code IYP (Phantom, Anthropomorphic, Nuclear), a Class I device regulated under 21 CFR 892.1370. Elscint, Inc. has at least 10 other 510(k) clearances on record.

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)

FDA data resources