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Revolution Frontier

by GE Hangwei Medical Systems Co., Ltd.

Ref Revolution Frontier

Revolution Frontier is a device classified as Class IIb in the EU and Class II in the US made by GE Hangwei Medical Systems Co., Ltd., registered in EUDAMED on 27 Jan 2022 (Basic UDI-DI 8406821BUG00202GS), cleared under FDA 510(k) K120833 on 12 Jun 2012 and listed in FDA GUDID since 16 Aug 2022 (UDI-DI 00195278362230), active as of 22 Oct 2026. One FDA recall is linked to it.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K120833

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195278362230 UDI-DI Date16 Aug 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8406821BUG00202GS Basic UDI-DI 00195278362230UDI-DIDate27 Jan 2022RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK120833 Date12 Jun 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8406821BUG00202GS registered 27 Jan 2022 Active
  • FDA 510(k) K120833 decided 12 Jun 2012 Active
  • FDA GUDID UDI-DI 00195278362230 listed 16 Aug 2022 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0609-2025 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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K120833
  2. Registered EUDAMED 8406821BUG00202GS
  3. Listed FDA GUDID 00195278362230
  4. Recall initiated FDA recalls Z-0609-2025

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Revolution Frontier EUDAMED
Revolution GUDID
Generic name
Full-body CT system
Device name
Revolution Frontier Gen 3_HD Refresh Package
Model / reference
Revolution Frontier EUDAMED
Frontier MDR GUDID
Primary DI / UDI-DI
00195278362230
Basic UDI-DI
8406821BUG00202GS
510(k) Number
FDA product code
JAK
EMDN code
Z11030605 Computed tomographs - 64 layers or more but less than 128 layers
GMDN term
Full-body CT system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1750
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Revolution Frontier
GUDID
Frontier MDR
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.

Manufacturer details

EUDAMED SRN
CN-MF-000009292
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS.

Other devices from GE Hangwei Medical Systems Co., Ltd.

See all devices from GE Hangwei Medical Systems Co., Ltd. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (22, all answered No)