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Revolution ACT

by GE Hangwei Medical Systems Company Ltd.

Ref Revolution ACT

Revolution ACT 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-00840682135313), cleared under FDA 510(k) K171013 on 5 Jun 2017 and listed in FDA GUDID since 27 Oct 2017 (UDI-DI 00840682135313), active as of 7 Nov 2026.

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

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171013

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-00840682135313 Basic UDI-DI 00840682135313UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682135313 UDI-DI Date27 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171013 Date5 Jun 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00840682135313 registered 22 Oct 2026 Active
  • FDA 510(k) K171013 decided 5 Jun 2017 Active
  • FDA GUDID UDI-DI 00840682135313 listed 27 Oct 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171013
  2. Listed FDA GUDID 00840682135313
  3. Registered EUDAMED B-00840682135313

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  • Withdrawn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
Revolution ACT EUDAMED
Revolution GUDID
Generic name
Full-body CT system
Model / reference
Revolution ACT EUDAMED
ACT GUDID
Primary DI / UDI-DI
00840682135313
Basic UDI-DI
B-00840682135313
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
Revolution ACT
GUDID
ACT
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 (K171013)

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
  • Manufacturing date
Other properties (19, all answered No)