Shimadzu Whole Body X-Ray CT Scanner SCT-4500TE

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

510(k) Number

K915623 ↗

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-4500TE Whole Body X-Ray CT Scanner used for?

  The Shimadzu SCT-4500TE is designed for diagnostic radiography, enabling physicians to assess internal body structures with high precision. It generates cross-sectional images by reconstructing axial plane data from multiple angular x-ray transmissions, providing detailed internal visualizations for clinical evaluation.

• Is the SCT-4500TE a single-use or reusable device?

  The SCT-4500TE is a reusable medical device. It requires regular maintenance, calibration, and adherence to manufacturer guidelines to ensure consistent performance and safety during repeated use in clinical settings.

• What components does the SCT-4500TE include?

  This system includes signal analysis equipment, display components, patient support systems, and associated hardware necessary for computed tomography imaging. These integrated features enable accurate data acquisition and visualization for diagnostic purposes.

• How should the SCT-4500TE be stored and operated?

  Proper storage and operational conditions are critical to maintain performance and safety. The manufacturer provides specific guidelines for environmental and handling requirements, which must be followed to ensure the device operates reliably and delivers accurate imaging results.

• What regulatory pathway does the SCT-4500TE follow?

  The SCT-4500TE is regulated under the FDA 510(k) clearance process, specifically with clearance number K915623. It is classified as a Class II device with Special Controls and was determined to be substantially equivalent to a predicate device through the Radiology Advisory Committee review.