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Venue; Venue Go; Venue Fit; Venue Sprint

by GE Medical Systems Ultrasound and Primary Care Diagnostics

510(k) K251322

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251322↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK251322 Date25 Jul 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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 · 510(k)

510(k) Number
FDA Product Code
IYN
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Venue series comprises portable ultrasound systems designed for point-of-care imaging. These devices fall under the category of diagnostic ultrasound systems, enabling real-time visualization of internal body structures for clinical assessment. Each model—Venue, Venue Go, Venue Fit, and Venue Sprint—is engineered for flexibility, delivering high-resolution imaging with features tailored to various clinical settings. The systems incorporate wireless probe capabilities and AI-enhanced workflows to streamline diagnostic processes.

These devices are intended for use in clinical environments requiring infection control, such as hospitals, emergency departments, and outpatient clinics. Supplied as reusable systems, they undergo regulatory compliance under FDA 510(k) clearance and MDR authorization. The Venue series includes models with varying portability and footprint sizes, including the Venue Sprint for maximum mobility and the Venue Fit for compact spaces. Storage and maintenance protocols align with manufacturer guidelines for reusable medical devices, ensuring sterility and operational readiness.

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

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical settings is the Venue series of ultrasound systems best suited for, and how does its portability factor into that decision?

    The Venue series is designed for point-of-care imaging in environments where mobility and infection control are critical, such as hospitals, emergency departments, and outpatient clinics. The different models—Venue Sprint (maximized mobility), Venue Fit (compact spaces), and the others—offer varying portability and footprint sizes to accommodate different clinical workflows. Their wireless probe capabilities and portable design make them ideal for scenarios where quick, flexible imaging is needed, such as bedside assessments or mobile diagnostic services.

  • Are these ultrasound systems single-use or reusable, and what does that mean for maintenance and sterility?

    The Venue series is supplied as a reusable system, meaning it is intended for repeated use across multiple patients. To maintain sterility and operational readiness, these devices must follow manufacturer-provided storage and maintenance protocols, which are designed for reusable medical equipment. This includes regular cleaning, disinfection, and calibration to ensure compliance with infection control standards in clinical settings.

  • How does the Venue series incorporate advanced technology to improve diagnostic workflows, and what are the key features that set it apart?

    The Venue series integrates wireless probe capabilities and AI-enhanced workflows to streamline diagnostics. These features help reduce setup time, improve image quality, and enable faster assessments of internal body structures in real-time. The AI tools are likely designed to assist clinicians by automating routine tasks, such as image optimization or annotation, thereby enhancing efficiency without compromising diagnostic accuracy.

  • What regulatory pathways have the Venue series undergone, and how does this affect its use in clinical environments?

    The Venue series has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming its compliance with regulatory standards for diagnostic ultrasound systems. These pathways ensure that the devices meet safety and performance requirements for use in clinical settings, including hospitals and emergency departments. The clearance also indicates that the devices are deemed substantially equivalent to legally marketed predecessors, reinforcing their reliability for point-of-care imaging.