Home / 510(k) Clearances / K875370

510(k) K875370

SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX by Shimadzu Precision Instruments, Inc. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1988
Date Received
December 31, 1987
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 Shimadzu Precision Instruments, Inc.

  • K940294 — SHIMADZU MOBILE X-RAY SYSTEMS (March 16, 1994)
  • K890913 — SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT (September 6, 1989)
  • K884598 — SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 (April 20, 1989)
  • K884477 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B (March 15, 1989)
  • K875378 — SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION (November 16, 1988)
  • K882311 — SHIMADZU LATERAL C-ARM MH-31 (September 14, 1988)
  • K881674 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC (September 2, 1988)
  • K874910 — SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200 (July 1, 1988)
  • K881795 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K (July 1, 1988)
  • K874946 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60 (March 3, 1988)

Other clearances for product code JAK

  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K252249 — Extremity CT Imaging System (March 13, 2026)
  • K260167 — Bunkerhill Contrast AVC (March 6, 2026)
  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K260169 — AV Cardiac CT (March 5, 2026)
  • K253173 — uCT 780 with uWS-CT-Dual Energy Analysis (January 20, 2026)
  • K252217 — CT VScore+ (November 28, 2025)
  • K251805 — syngo.CT Dual Energy (October 15, 2025)
  • K250662 — Bunkerhill MAC (October 3, 2025)
  • K250766 — LungQ 4 (October 2, 2025)