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Revolution Vibe

by GE Hangwei Medical Systems Co., Ltd.

Part of a family of 6 devices: see the family page

Ref B7920HEC/B7920HFC, Revolution Vibe

Revolution Vibe (B7920HEC/B7920HFC) is a full-body CT system (EU MDR Class IIb; FDA Class II; FDA product code JAK, System, X-Ray, Tomography, Computed) made by GE Hangwei Medical Systems Co., Ltd., cleared under FDA 510(k) K250941 on 1 Aug 2025, registered in EUDAMED on 14 Mar 2022 (Basic UDI-DI 8406821BUG00213GX) and listed in FDA GUDID since 22 Aug 2025 (UDI-DI 00198953098592), active as of 22 Oct 2026.

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

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250941

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 Number00198953098592 UDI-DI Date22 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK250941 Date1 Aug 2025DecidedStatusActive
European UnionCE/MDR EUDAMED Number8406821BUG00213GX Basic UDI-DI Date14 Mar 2022RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K250941 decided 1 Aug 2025 Active
  • EUDAMED Basic UDI-DI 8406821BUG00213GX registered 14 Mar 2022 Active
  • FDA GUDID UDI-DI 00198953098592 listed 22 Aug 2025 Listed

Timeline

3 dated events

  1. Registered EUDAMED 8406821BUG00213GX
  2. Cleared FDA 510(k) K250941
  3. Listed FDA GUDID 00198953098592

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  • Withdrawn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 Vibe EUDAMED
Revolution GUDID
Generic name
Full-body CT system
Device name
Revolution Apex Select
Model / reference
B7920HEC/B7920HFC EUDAMED
Revolution Vibe EUDAMED
Vibe GUDID
Primary DI / UDI-DI
00198953098592, 00195278943934
Basic UDI-DI
8406821BUG00213GX
510(k) Number
FDA product code
JAK
EMDN code
Z11030607 Computed tomographs - 256 layers or more
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
Italy
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
B7920HEC/B7920HFC
Revolution Vibe
GUDID
Vibe
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 - 256 LAYERS OR MORE.

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
  • Manufacturing date
Other properties (21, all answered No)