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Operator Console

by GE Hangwei Medical Systems Company Ltd.

Ref Operator Console (for BightSpeed Elite / BrightSpeed Elite Select)

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

9 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00195278505798 Basic UDI-DI 00195278505798UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00195278505798 UDI-DI Date17 Apr 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

9 recalls · FDA

    • Terminated Z-2586-2018 FDA Class II initiated 24 May 2018

    Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

  • 2 recalls, same reason

    • Terminated Z-2873-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2872-2018 FDA Class II initiated 27 Apr 2018

    GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.

  • 2 recalls, same reason

    • Terminated Z-2188-2017 FDA Class II initiated 19 May 2017
    • Terminated Z-2186-2017 FDA Class II initiated 19 May 2017

    It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

    • Terminated Z-0840-2014 FDA Class II initiated 9 Oct 2013

    There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient's images and another patient's name in the footer. This is also an issue when within Manual Film Composer, if a color image is selected for printing, another patient's black and white image appears in the preview screen

    • Terminated Z-2214-2011 FDA Unclassified (pre-2012) initiated 19 Jan 2011

    GE Healthcare has become aware of a potential set of circumstances that could cause X-ray continuation during an unexpected table stop on certain BrightSpeed systems (BrightSpeed Excel/Edge/Elite Select and BrightSpeed Elite Computed Tomography X-ray Systems ) if this event were to occur on your system, patient safety may be impacted.

  • 2 recalls, same reason

    • Terminated Z-0369-2011 FDA Unclassified (pre-2012) initiated 3 Sep 2010
    • Terminated Z-0368-2011 FDA Unclassified (pre-2012) initiated 3 Sep 2010

    GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Operator Console (for BightSpeed Elite / BrightSpeed Elite Select) EUDAMED
Operator Console GUDID
Generic Name
Full-body CT system
Model / Reference
Operator Console (for BightSpeed Elite / BrightSpeed Elite Select) EUDAMED
for BrightSpeed Elite and BrightSpeed Elite Select GUDID
Primary DI / UDI-DI
00195278505798
Basic UDI-DI
B-00195278505798
510(k) Number
FDA Product Code
JAK
EMDN Code
Z11030603 Computed tomographs - 16 layers or more but less than 64 layers
GMDN Term
Full-body CT system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1750
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Operator Console (for BightSpeed Elite / BrightSpeed Elite Select)
GUDID
for BrightSpeed Elite and BrightSpeed Elite Select
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K082816)

Other devices from GE Hangwei Medical Systems Company Ltd.

See all devices from GE Hangwei Medical Systems Company Ltd. →

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No