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510(k) K874934

UNIVERSAL EXAMINATION TABLE by Imatron, Inc. — Product Code KXJ

K874934 is an FDA 510(k) premarket notification submitted by Imatron, Inc. for the device "UNIVERSAL EXAMINATION TABLE". The FDA issued a decision of Substantially Equivalent on January 19, 1988. The device falls under product code KXJ (Table, Radiologic), a Class II device regulated under 21 CFR 892.1980. Imatron, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1988
Date Received
December 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiologic
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type

Other clearances by Imatron, Inc.

  • K001550 — EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTE (December 11, 2000)
  • K000359 — EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-15 (March 17, 2000)
  • K992740 — EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-15 (November 9, 1999)
  • K972903 — IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS (November 4, 1997)
  • K972879 — ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION (October 15, 1997)
  • K913352 — C-150 ULTRAFAST CT SCANNER (November 29, 1991)
  • K872615 — IMATRON C-100 ULTRAFAST CT SCANNER (September 23, 1987)
  • K864046 — C-IOO MOBILE CINE CT UNIT (November 10, 1986)
  • K840131 — COMPUTED TOMOGRAPHY CALIBRATION PHANT (February 21, 1984)
  • K828669 — COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100 (January 14, 1983)

Other clearances for product code KXJ

  • K050190 — APOLLO (March 25, 2005)
  • K963905 — RADIOGRAPHIC ITT TABLE (November 12, 1996)
  • K955414 — XRT 400 (July 24, 1996)
  • K951146 — IMAGING TABLE (May 4, 1995)
  • K950068 — CARBON FIBER COUCH INSERT (April 6, 1995)
  • K950442 — INFRARED EXPOSURE HAND SWITCH (March 31, 1995)
  • K940696 — SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5 (March 16, 1994)
  • K931724 — ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES (June 14, 1993)
  • K926407 — MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM (March 31, 1993)
  • K922098 — CAG-02A (July 27, 1992)

FDA data resources