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Ligthspeed 3.0 Ct Scanner System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K002978

by Ge Medical Systems

Identifiers

510(k) Number
K002978 FDA 510(k)
FDA Product Code
JAK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The LightSpeed 3.0 CT Scanner System is a computed tomography (CT) device designed for high-resolution cross-sectional imaging of the body. It employs X-ray technology to generate detailed images of internal structures, including bones, blood vessels, and soft tissues, supporting diagnostic evaluations in radiology. Its architecture enables rapid scanning and multi-slice acquisition, enhancing clinical workflow efficiency for conditions requiring precise anatomical visualization. The system falls under the category of Class II medical devices, as classified by regulatory authorities.

This CT scanner system is intended for use in radiology departments within healthcare facilities, where it is operated by trained radiologic technologists and interpreted by radiologists. Supplied as a complete imaging solution, it requires installation in a dedicated CT suite with appropriate shielding and power infrastructure. The device is not described as single-use or reusable in the specifications, and no sterility or MRI safety information is provided. Authorised for commercial distribution in the United States under FDA 510(k) clearance (K002978), the system adheres to regulatory standards for computed tomography imaging devices as of the clearance date.

Frequently asked questions

What is the LightSpeed 3.0 CT Scanner System designed for?

The LightSpeed 3.0 CT Scanner System is specifically designed for high-resolution cross-sectional imaging of internal body structures, including bones, blood vessels, and soft tissues. It uses X-ray technology to generate detailed images that support diagnostic evaluations in radiology, making it ideal for conditions requiring precise anatomical visualization.

How is the LightSpeed 3.0 CT Scanner System supplied and installed?

The LightSpeed 3.0 CT Scanner System is supplied as a complete imaging solution, intended for installation in a dedicated CT suite within healthcare facilities. It requires appropriate shielding and power infrastructure to ensure safe and effective operation. The system is not intended for single-use or reusable applications, and installation should be performed by trained professionals.

Is the LightSpeed 3.0 CT Scanner System single-use or reusable?

The LightSpeed 3.0 CT Scanner System is not described as single-use or reusable in its specifications. It is designed as a durable imaging device intended for repeated use in clinical settings, provided it is properly maintained and serviced according to manufacturer guidelines.

What regulatory clearance does the LightSpeed 3.0 CT Scanner System hold?

The LightSpeed 3.0 CT Scanner System holds FDA 510(k) clearance (K002978) for commercial distribution in the United States. This clearance was granted under the Radiology advisory committee and is classified as a substantially equivalent device, adhering to regulatory standards for computed tomography imaging.

Who operates and interprets images from the LightSpeed 3.0 CT Scanner System?

The LightSpeed 3.0 CT Scanner System is operated by trained radiologic technologists in radiology departments, while the resulting images are interpreted by radiologists. This division of labor ensures that imaging is conducted and assessed by qualified professionals, maintaining clinical accuracy and safety.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GE LightSpeed CT Price and Buying Guide (2026) | Medical Outfitters, LIGTHSPEED 3.0 CT SCANNER SYSTEM - fda.innolitics.com, LIGTHSPEED 3.0 CT SCANNER SYSTEM (K002978) - FDA 510 (k), GE Healthcare Ligthspeed 3.0 CT Scanner - allmed.wiki

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ge Medical Systems

Sources (1)

  • FDA 510(k) K002978 24 fields · synced Oct 5, 2026