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Venue Go R5 UPG

by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Ref Venue Go R5 UPGModel Venue Go

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220800↗

+1 more

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195278687777 UDI-DI Date10 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK220800 Date21 Jun 2022IssuedStatusActive
European UnionCE/MDR EUDAMED Number8406821BUG00284HN Basic UDI-DI 00195278687777UDI-DIDate10 Feb 2022RegisteredStatusActive

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

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1555-2025 FDA Class II initiated 6 Mar 2025

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

    • Ongoing Z-2652-2023 FDA Class II initiated 6 Sep 2023

    Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling.

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  • Withdrawn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) · GUDID

Trade Name
Venue Go R5 UPG EUDAMED
Venue Go GUDID
Generic Name
General-purpose ultrasound imaging system
Model / Reference
Venue Go EUDAMED
Venue Go R5 UPG EUDAMED
R5 UPG GUDID
Primary DI / UDI-DI
00195278687777
Basic UDI-DI
8406821BUG00284HN
Direct Marketing DI
00195278687777
510(k) Number
FDA Product Code
IYN, IYO, ITX
EMDN Code
Z11040101 Internal ultrasound scanners
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1550, 892.1560, 892.1570
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Venue Go
Venue Go R5 UPG
GUDID
R5 UPG
Device ClassEUDAMED
Class IIa
GUDID
Class II

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

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Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No