Computed Tomography X-Ray System (K903763)

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

Full name

Computed Tomography X-Ray System

510(k) Number

K903763 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Generator, High Volt, X-Ray, Diag. MPX80

  Class I

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  Class II

  FDA 510(k) K872526 Active Cleared 23 Sep 1987

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  Class II

  FDA 510(k) K864222 Active Cleared 4 Mar 1987

See all devices from General Electric Co. →

• What is the primary purpose of this Computed Tomography X-Ray System, and where is it typically used?

  This device is designed to create detailed cross-sectional images of the body by reconstructing x-ray data from multiple angles. It is intended for diagnostic purposes, allowing radiologists to visualize internal structures with high precision. It is specifically meant for use in radiology departments within healthcare settings.

• Is this device single-use or reusable, and does it require sterilization?

  The Computed Tomography X-Ray System is a traditional, non-reusable device. Since it is not intended for invasive procedures or contact with sterile body areas, it does not require sterilization for its intended use.

• How was this device’s regulatory clearance determined, and what does that mean for its use?

  The device was cleared by the FDA under a 510(k) submission, classified as *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for diagnostic imaging in radiology.

• Does this system come in different sizes or configurations, or is it a single model?

  The regulatory data does not specify any variations in size or model configurations for this Computed Tomography X-Ray System. It is supplied as a standard diagnostic imaging device without noted differences in physical dimensions or technical variants.

• Who is the manufacturer, and how can I contact them for inquiries?

  The manufacturer is General Electric Co., based in Milwaukee, WI. For inquiries, you can contact Larry A. Kroger at the address provided in the submission: *P.O. Box 414, Milwaukee, WI 53201*.