Ultrasound Workspace (UWS 6.0)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241659 FDA 510(k)
- FDA Product Code
- QIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ultrasound Workspace (UWS 6.0) is a software platform for cardiovascular ultrasound image analysis, review, reporting, and management. It integrates automated clinical tools to enhance diagnostic accuracy and consistency across multiple imaging modalities in a vendor-neutral environment.
The device is supplied as a software application for use with compatible ultrasound systems and requires installation on a qualified computing platform. Authorized for use in the United States under FDA 510(k) clearance (K241659) and compliant with EU MDR, it is intended for single-use sessions within clinical radiology settings. No specific sterility or MRI safety classifications are stated, and storage follows standard software licensing requirements.
Frequently asked questions
What types of ultrasound imaging modalities does the Ultrasound Workspace (UWS 6.0) support for analysis and review?
The Ultrasound Workspace (UWS 6.0) integrates with multiple cardiovascular ultrasound imaging modalities within a vendor-neutral environment. While the exact modalities aren’t listed, its design emphasizes automated clinical tools for cardiovascular diagnostics, meaning it is likely compatible with transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and other cardiac-focused ultrasound techniques. The platform is built to enhance diagnostic accuracy and consistency across these modalities.
Is the Ultrasound Workspace (UWS 6.0) designed for reuse across multiple patient sessions, or is it intended for single-use per patient?
The UWS 6.0 is explicitly intended for single-use sessions within clinical radiology settings. This means it is not designed to be reused across multiple patient encounters but rather for one diagnostic session at a time. The software’s vendor-neutral and automated tool integration aligns with workflows where each patient’s imaging data is processed independently, reducing the risk of data contamination or cross-patient errors.
How is the Ultrasound Workspace (UWS 6.0) installed and what computing platform requirements must be met?
The UWS 6.0 is supplied as a software application that requires installation on a qualified computing platform. While the exact hardware specifications aren’t detailed, Philips Ultrasound LLC typically supports standard clinical-grade workstations with sufficient processing power, memory, and storage to handle ultrasound image analysis. The platform must be compatible with the manufacturer’s recommended operating systems and system configurations to ensure optimal performance and integration with existing ultrasound systems.
Does the Ultrasound Workspace (UWS 6.0) require any special storage conditions beyond standard software licensing?
No special storage conditions beyond standard software licensing requirements are stated for the UWS 6.0. Since it is a software application, it should be stored on a secure, authorized computing platform with proper access controls and backups in compliance with institutional IT policies. The lack of mention of sterility or environmental constraints (e.g., temperature, humidity) confirms that storage follows typical software deployment guidelines rather than physical device storage protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ultrasound Workspace - Philips, PDF FDA_IFU_UWS_6.0_ENG - documents.philips.com, PHILIPS Ultrasound Workspace 6.0 Owner's Manual - Manuals+
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K241659 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Ultrasound LLC
- FDA Applicant
- Philips Ultrasound, LLC
Sources (2)
- FDA 510(k) K241659 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026