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Venue Go

by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC United States EUDAMED510(k)

Ref Venue Go R5WModel Venue Go EMDN Z11040101

Regulatory status

as of 25 Oct 2026

Recall ongoing on a related submission. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK240053 Date10 Jun 2024IssuedStatusActive
European UnionCE/MDR EUDAMED Number8406821BUG00284HN Basic UDI-DIDate10 Feb 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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 America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Certificates: none listed in EUDAMED

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1555-2025 FDA Class II initiated 6 Mar 2025 via K240053, on the same 510(k)

    The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

Model / Reference
Venue Go, Venue Go R5W
Primary DI / UDI-DI
00195278703446
Basic UDI-DI
8406821BUG00284HN
Direct Marketing DI
00195278703446
EMDN Code
Z11040101 Internal ultrasound scanners
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000016119
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from GE Medical Systems Ultrasound and Primary Care Diagnostics LLC

See all devices from GE Medical Systems Ultrasound and Primary Care Diagnostics LLC →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED f50a06e1-ffb7-4898-85b8-717142bc7d18 61 fields · synced 22 Oct 2026
  • FDA 510(k) K240053 1 fields · synced 18 May 2026