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Lightspeed 2.0CT Scanner System

by GE Medical Systems, Inc.

510(k) K000300

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000300 Date15 Feb 2000ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JAK
Device class
Class II
Regulation
21 CFR Part 892.1750
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LightSpeed 2.0 CT Scanner System is a computed tomography (CT) imaging device designed for high-resolution cross-sectional imaging of the body. It employs multiple detector rows to acquire volumetric data, enabling faster scan times and improved diagnostic capabilities for radiology applications.

This system is supplied as a reusable medical device and is intended for use in radiology departments. It has received FDA 510(k) clearance under the Traditional pathway, classified under product code JAK, and is regulated as a Class 2 Radiology device. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and compliance with regulatory standards.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of medical imaging tasks is the LightSpeed 2.0 CT Scanner System primarily designed for?

    The LightSpeed 2.0 CT Scanner System is specifically designed for high-resolution cross-sectional imaging of the body. Its multiple detector rows allow for faster scan times and improved diagnostic imaging, making it suitable for radiology applications such as detailed anatomical visualization, emergency diagnostics, and routine diagnostic evaluations.

  • Is the LightSpeed 2.0 CT Scanner System intended for single-use or reusable in clinical settings?

    The LightSpeed 2.0 CT Scanner System is supplied as a reusable medical device, meaning it is built for repeated use in radiology departments. Proper storage and maintenance, as outlined by the manufacturer, are required to ensure its functionality and compliance with regulatory standards.

  • How was the FDA clearance for this device determined, and what regulatory pathway was followed?

    The LightSpeed 2.0 CT Scanner System received FDA clearance under the Traditional 510(k) pathway, where it was determined to be *substantially equivalent* to a legally marketed predicate device. The clearance was granted by the FDA’s Radiology (RA) advisory committee, and the device is classified under product code JAK as a Class 2 Radiology device.

  • Who should I contact if I need further information about the LightSpeed 2.0 CT Scanner System’s specifications or compliance?

    For additional details regarding the LightSpeed 2.0 CT Scanner System, including specifications or compliance matters, you may reach out to GE Medical Systems, Inc. at the address provided in the FDA submission: P.O. Box 414, Milwaukee, WI 53201. The contact listed is Larry A. Kroger.