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Optima CT520

by GE Hangwei Medical Systems Company Ltd.

Ref Optima CT520

Optima CT520 is a device classified as Class IIb in the EU and Class II in the US made by GE Hangwei Medical Systems Company Ltd., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI B-00840682102568), cleared under FDA 510(k) K123596 on 8 Feb 2013 and listed in FDA GUDID since 20 May 2016 (UDI-DI 00840682102568), active as of 7 Nov 2026. 5 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123596

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00840682102568 Basic UDI-DI 00840682102568UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682102568 UDI-DI Date20 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123596 Date8 Feb 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00840682102568 registered 22 Oct 2026 Active
  • FDA 510(k) K123596 decided 8 Feb 2013 Active
  • FDA GUDID UDI-DI 00840682102568 listed 20 May 2016 Listed

Recalls

5 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0604-2025 FDA Class II initiated 5 Nov 2024
    • Ongoing Z-0601-2025 FDA Class II initiated 5 Nov 2024

    GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.

    • Terminated Z-2585-2018 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).

    • Terminated Z-2185-2017 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

Timeline

8 dated events

  1. Cleared FDA 510(k) K123596
  2. Recall initiated FDA recalls Z-0840-2014
  3. Listed FDA GUDID 00840682102568
  4. Recall initiated FDA recalls Z-2185-2017
  5. Recall initiated FDA recalls Z-2585-2018
  6. Recall initiated FDA recalls Z-0604-2025
  7. Recall initiated FDA recalls Z-0601-2025
  8. Registered EUDAMED B-00840682102568

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Optima CT520 EUDAMED
Optima GUDID
Generic name
Full-body CT system
Model / reference
Optima CT520 EUDAMED
CT520 GUDID
Primary DI / UDI-DI
00840682102568
Basic UDI-DI
B-00840682102568
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
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Optima CT520
GUDID
CT520
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Full-body CT system

Cleared under the same submission (K123596)

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS.

Other devices from GE Hangwei Medical Systems Company Ltd.

  • Operator Console

    Class II

  • Optima CT680 Expert Open recall

    Class II

  • Revolution Ascend Sliding

    Class II

  • Optima Advance Open recall

    Class II

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

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (20, all answered No)