Shimadzu Whole Body X-Ray CT Scanner SCT-2000T-11

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K874767 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Micro-Flow Spectrophotometer Cl-720

  Class I

  FDA 510(k) K801957 Active Cleared 26 Sep 1980

• Shimadzu Mammographic Stand Mr-30

  Class II

  FDA 510(k) K875377 Active Cleared 12 Feb 1988

• Shimadzu Catheterization C-Arm Stand ER-200

  Class II

  FDA 510(k) K875372 Active Cleared 12 Feb 1988

• Shimadzu Whole Body X-Ray CT Scanner Sct-3000TX

  Class II

  FDA 510(k) K875370 Active Cleared 18 May 1988

• Sdu 800 Diagnostic Ultrasound Instrument

  Class II

  FDA 510(k) K890913 Active Cleared 6 Sep 1989

• Shimadzu X-Ray High Voltage Generator UD150K

  Class I

  FDA 510(k) K881795 Active Cleared 1 Jul 1988

See all devices from Shimadzu Precision Instruments, Inc. →

• What is the primary function of the Shimadzu SCT-2000T-11?

  This device is a diagnostic imaging system engineered to perform whole-body computed tomography. It uses X-ray technology to generate cross-sectional images of the body, which are intended for clinical evaluation by medical professionals.

• What is the regulatory status of this CT scanner?

  The Shimadzu SCT-2000T-11 is identified under FDA 510(k) clearance number K874767. This indicates that the device was reviewed and determined to be substantially equivalent to other legally marketed devices under the radiology advisory committee.

• Who is the manufacturer of this imaging system?

  The device is manufactured by Shimadzu Precision Instruments, Inc., located in Torrance, California. They are the applicant responsible for the 510(k) submission associated with this specific model.