Skip to content

3DXR

by GE Medical Systems SCS

Ref 5967424, 5932304

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243446↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK243446 Date25 Feb 2025IssuedStatusActive
European UnionCE/MDR EUDAMED Number8406821BUG00343HD Basic UDI-DI Date29 Dec 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / Reference
5967424, 5932304
Primary DI / UDI-DI
00195278884466, 00195278640437
Basic UDI-DI
8406821BUG00343HD
Direct Marketing DI
00195278884466
00195278640437
EMDN Code
Z11030192 Digital angiography systems - medical device software
Device Class
Class IIa
Special Device Type
Software
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000687

Other devices from GE Medical Systems SCS

See all devices from GE Medical Systems SCS →

Properties

Other properties (13)

  • Sterile: 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No