Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-6800TX

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

510(k) Number

K973329 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Shimasonic Linear/Convex Diagnostic Ultrasound System

  Class II

  FDA 510(k) K973802 Active Cleared 4 Mar 1998

• Shimadzu Whole Body X-Ray CT Scanner Sct-7000TX

  Class II

  FDA 510(k) K955255 Active Cleared 9 Feb 1996

• Shimadzu X-Ray High-Voltage Generator XUD150K

  Class I

  FDA 510(k) K911339 Active Cleared 16 Apr 1991

• Shimadzu X-Ray High-Voltage Generator XUD150B

  Class I

  FDA 510(k) K911280 Active Cleared 17 Jun 1991

• Shimadzu Whole Body X-Ray Computed Tomography Scanner Sct-7000TX W/Fluro Option

  Class II

  FDA 510(k) K984156 Active Cleared 21 Apr 1999

• MU125M Mobile X-Ray System

  Class II

  FDA 510(k) K920393 Active Cleared 6 Apr 1992

See all devices from Shimadzu Medical Systems →

• What is the Shimadzu SCT-6800TX Whole Body X-Ray Computed Tomography Scanner used for?

  The Shimadzu SCT-6800TX is designed for whole-body imaging using X-ray technology to produce cross-sectional images of internal structures. These images help clinicians visualize anatomical features with high detail, supporting diagnostic evaluations in radiology settings. Its dual scanning modes—spiral and conventional—provide flexibility for different clinical needs, such as vascular studies or general anatomical assessment.

• Is the SCT-6800TX a single-use or reusable device?

  The Shimadzu SCT-6800TX is a reusable medical imaging system. It is not intended for single-use applications and requires proper installation, maintenance, and calibration as outlined by the manufacturer. Reusability is standard for high-end CT scanners, ensuring durability and cost-effectiveness for long-term clinical use.

• What distinguishes the SCT-6800TX’s imaging capabilities?

  The SCT-6800TX incorporates a slip-ring mechanism, which allows continuous data acquisition during rotation. This feature enables seamless spiral scanning, improving efficiency and image quality for complex anatomical regions. The scanner’s flexibility in scanning modes (spiral and conventional) further enhances its adaptability for various diagnostic procedures.

• Does the SCT-6800TX require sterility or special handling?

  The available data does not specify sterility requirements for the SCT-6800TX, as it is a reusable imaging system rather than a disposable device. However, standard infection control protocols should be followed for all components that come into contact with patients, such as patient tables or accessories. The device itself does not require sterilization but must be regularly cleaned and maintained per manufacturer guidelines.

• What regulatory pathway was followed for FDA clearance of this device?

  The Shimadzu SCT-6800TX received FDA 510(k) clearance under product code JAK, classified as a Class II device under special controls. The clearance was granted through a traditional review process by the Radiology Advisory Committee (RA), with a decision date of October 8, 1997. This pathway confirms the device’s substantial equivalence to a predicate, ensuring compliance with safety and performance standards for clinical use.