Venue Fit R4W
by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC EUDAMED510(k)GUDID
Active
Ref Venue Fit R4W, Venue Fit R5 UPG, Venue R6W, Venue Fit R5WModel Venue Fit, Venue
Overview
The Venue Fit R4W is a portable point-of-care ultrasound system (Nomenclature Code: Z11040101), classified as Class IIa. It is designed for real-time imaging and diagnostic measurements, enabling clinicians to perform focused assessments at the bedside or in resource-limited settings. The device supports applications such as lung, cardiac, vascular, and nerve-block evaluations, facilitating rapid decision-making in emergency and critical care environments. Its compact and efficient design prioritises precision and ease of use in dynamic clinical settings.
The Venue Fit R4W is supplied as a non-sterile, single-use device (sterility status: 0) and is not intended for reprocessing or reuse. It is not MRI-safe, implantable, or intended for administration of medicines. The system is authorised under FDA 510K and MDR compliance frameworks, ensuring adherence to regulatory standards for medical imaging devices. Storage and handling should follow manufacturer guidelines to maintain device integrity, though specific sterility or reprocessing protocols are not applicable. The device is distributed under the UDI DI 00195278516503 and is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC.
Regulatory status
Recall ongoing. 1 ongoing FDA recall. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number00195278516503 | Date10 Jul 2024 | StatusIn distribution |
| United States | FDA 510(k) 510(k) | NumberK234106 | Date10 Jun 2024 | StatusActive |
| European Union | CE/MDR EUDAMED | Number8406821BUG00285HQ | Date17 Feb 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- United States
- European Union
Recalls
-
- Ongoing Z-1556-2025
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
Specification
- Full name
- Venue Fit
- Trade Name
- Venue Fit EUDAMEDGUDIDVenue Fit R5 UPG EUDAMEDVenue EUDAMED
- Generic Name
- General-purpose ultrasound imaging system
- Model / Reference
- Venue Fit EUDAMEDVenue Fit R4W EUDAMEDVenue Fit R5 UPG EUDAMEDVenue EUDAMEDVenue R6W EUDAMEDVenue Fit R5W EUDAMEDR5 UPG GUDID
- Primary DI / UDI-DI
- 00195278516503, 00195278703484, 00198953001349, 00195278703217
- Basic UDI-DI
- 8406821BUG00285HQ, 8406821BUG00053GZ
- Direct Marketing DI
- 00195278516503001952787034840019895300134900195278703217
- 510(k) Number
- FDA Product Code
- ITX, IYO, IYN
- EMDN Code
- Z11040101 Internal ultrasound scanners
- GMDN Term
- General-purpose ultrasound imaging system
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 892.1570, 892.1560, 892.1550
- Market of Registration
- FranceSpain
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Venue Fit Venue Fit R4W Venue Fit R5 UPG Venue Venue R6W Venue Fit R5W | R5 UPG |
| Device Class | Class IIa | 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
See all devices from GE Medical Systems Ultrasound and Primary Care Diagnostics LLC →
Questions
What types of clinical assessments can the Venue Fit R4W support, and why is this important for point-of-care settings?
The Venue Fit R4W supports real-time imaging for lung, cardiac, vascular, and nerve-block evaluations, enabling rapid diagnostic measurements at the bedside. This is particularly valuable in emergency or resource-limited settings where quick decision-making is critical, as it allows clinicians to assess patients without delays from transferring to a radiology department.
Is the Venue Fit R4W designed for reuse, and if not, what does this mean for infection control in clinical environments?
No, the Venue Fit R4W is explicitly labeled as a non-sterile, single-use device (sterility status: 0) and is not intended for reprocessing or reuse. This means each unit must be discarded after a single use to prevent cross-contamination, aligning with infection control best practices for disposable medical devices.
How should the Venue Fit R4W be stored, and are there any special considerations given its single-use nature?
While the device does not require sterility or reprocessing protocols (as it’s single-use), storage should follow the manufacturer’s guidelines to preserve its integrity. Since it’s not reusable, proper handling ensures functionality for its intended use—avoiding exposure to moisture, extreme temperatures, or physical damage that could compromise performance before use.
What regulatory frameworks does the Venue Fit R4W comply with, and how does this affect its use in different markets?
The device is authorized under FDA 510K (U.S.) and MDR (Medical Device Regulation) compliance frameworks, ensuring it meets stringent safety and performance standards in both markets. This dual authorization allows clinicians and buyers to rely on its regulatory validation for use in the U.S. and European Economic Area, though local healthcare policies may still apply.
Does the Venue Fit R4W have any limitations regarding compatibility with other medical equipment, such as MRI machines?
The Venue Fit R4W is not MRI-safe, meaning it should not be used in or near MRI environments. This is a critical consideration for facilities where patients may require both ultrasound and MRI procedures, as improper placement could pose risks to the device or the patient.
Properties
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