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CT Prospeed Family

by GE Medical Systems

510(k) K944013

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK944013 Date7 Feb 1995ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2224-2009 FDA Unclassified (pre-2012) initiated 1 Dec 2008

    During internal testing, GE Healthcare has recently determined that the collimator used on our CT/e and HiSpeed X/i families of Computed Tomography systems does not comply with the specific requirements in United States Title 21 of the Code of Federal Regulations, and IEC 60601-1-3, related to leakage radiation from the diagnostic source assembly, which includes the collimator. The excess leak

    • Terminated Z-0269-05 FDA Unclassified (pre-2012) initiated 21 Oct 2004 on shared 510(k) K944013

    The patient tables of the affected CT systems are supported by a hydraulic cylinder and a cylinder shaft (i.e. the upper shaft) which connects the tabletop to the table frame. GE received a report of a HiSpeed LX/I system table falling abruptly due to the filure of the upper shaft. No injuries were reported.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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, 6 Oct 2026

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

The CT Prospeed Family is a computed tomography (CT) system, classified as a System, X-ray, Tomography, Computed (product code JAK). It is a medical imaging device designed for diagnostic radiology applications.

The device received FDA 510(k) clearance (K944013) on February 7, 1995, following a traditional review process. It is manufactured by GE Medical Systems and is intended for use in radiology settings.

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