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510(k) K972903

IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS by Imatron, Inc. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1997
Date Received
August 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Other clearances by Imatron, Inc.

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  • K992740 — EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-15 (November 9, 1999)
  • 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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