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510(k) K840131

COMPUTED TOMOGRAPHY CALIBRATION PHANT by Imatron, Inc. — Product Code IXG

K840131 is an FDA 510(k) premarket notification submitted by Imatron, Inc. for the device "COMPUTED TOMOGRAPHY CALIBRATION PHANT". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code IXG (Phantom, Anthropomorphic, Radiographic), a Class I device regulated under 21 CFR 892.1950. Imatron, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1984
Date Received
January 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phantom, Anthropomorphic, Radiographic
Device Class
Class I
Regulation Number
892.1950
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)
  • K874934 — UNIVERSAL EXAMINATION TABLE (January 19, 1988)
  • K872615 — IMATRON C-100 ULTRAFAST CT SCANNER (September 23, 1987)
  • K864046 — C-IOO MOBILE CINE CT UNIT (November 10, 1986)
  • K828669 — COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100 (January 14, 1983)

Other clearances for product code IXG

  • K913243 — BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE (September 19, 1991)
  • K852528 — BONE DENSITY CT PHANTOM (September 26, 1985)
  • K834465 — SERIES OF DIAGNOSTIC PHANTOMS (February 21, 1984)

FDA data resources