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510(k) K001550

EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR by Imatron, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2000
Date Received
May 18, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Imatron, Inc.

  • 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)
  • K840131 — COMPUTED TOMOGRAPHY CALIBRATION PHANT (February 21, 1984)
  • K828669 — COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100 (January 14, 1983)

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