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510(k) K972903

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

K972903 is an FDA 510(k) premarket notification submitted by Imatron, Inc. for the device "IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS". The FDA issued a decision of Substantially Equivalent on November 4, 1997. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Imatron, Inc. has at least 10 other 510(k) clearances on record.

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.

  • 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)
  • 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)

Other clearances for product code JAK

  • K253560 — Enhanced Boundary for PCCT (June 24, 2026)
  • K253026 — Respiratory Gating for Scanners (2.1) (June 4, 2026)
  • K253596 — Aquilion ONE (TSX-308A/TSX-306A) V2.0 (May 20, 2026)
  • K253649 — Spectral CT Verida Family (March 27, 2026)
  • K252992 — CT Rembra RT; CT Areta RT; CT Rembra (March 23, 2026)
  • K253686 — True Definition DL (March 23, 2026)
  • K253520 — Photonova Spectra, Photonova Spectra Select (March 20, 2026)
  • K253574 — SOMATOM X.cite; SOMATOM X.ceed (March 20, 2026)
  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K252249 — Extremity CT Imaging System (March 13, 2026)

FDA data resources