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Revolution RT

by Ge Hangwei Medical Systems Co., Ltd. China EUDAMEDGUDID

Ref B81912DA, B7590AE

Product code JAKEMDN Z11030603

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195278809810 UDI-DIDate26 Dec 2024ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number08406821BUG004947P Basic UDI-DIDate23 Dec 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

2 recalls · FDA

    • Terminated Z-2581-2018 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-2184-2017 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.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Revolution RT EUDAMED
Revolution GUDID
Generic Name
Full-body CT system
Model / Ref / Catalog
B81912DA EUDAMED
B7590AE EUDAMED
RT GUDID
RevolutionRT GUDID
Primary DI / UDI-DI
00195278809810
Basic UDI-DI
08406821BUG004947P
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
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
B81912DA, B7590AE
GUDID
RT
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

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

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

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

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (20)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: 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

Sources (2)

  • EUDAMED 4040419c-a7d1-4517-a12e-dda722796ed5 61 fields · synced 22 Oct 2026
  • FDA UDI 8c90dc3b-94fe-421b-b5e4-d0851af1ac70 35 fields · synced 30 May 2026