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Lightspeed 4.0 Ct Scanner System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K013561

by Ge Medical Systems

Identifiers

510(k) Number
K013561 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 4.0 Ct Scanner System is a computed tomography (CT) scanner. It is a medical device used for diagnostic imaging purposes.

The device is supplied by GE Medical Systems and has been authorized with an FDA 510K clearance. It is classified under product code JAK and has been reviewed by the Radiology advisory committee. The device is available with the model number K013561.

Frequently asked questions

What is the Lightspeed 4.0 CT Scanner System used for?

The Lightspeed 4.0 CT Scanner System is used for diagnostic imaging purposes, providing computed tomography scans.

What is the model number of the Lightspeed 4.0 CT Scanner System?

The model number of the Lightspeed 4.0 CT Scanner System is K013561.

Who is the manufacturer of the Lightspeed 4.0 CT Scanner System?

The Lightspeed 4.0 CT Scanner System is manufactured by GE Medical Systems.

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: Die führende Kassensystem- und Bezahlplattform - Lightspeed …, Lightspeed | Login - Kounta, The Lightspeed Platform - Lightspeed Systems

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) K013561 24 fields · synced Oct 6, 2026