Identifiers
- 510(k) Number
- K971965 FDA 510(k)
- FDA Product Code
- LLZ 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)
The EasyVision RAD Acquisition System is a medical imaging software platform designed for radiology applications, enabling the acquisition, processing, and analysis of diagnostic images. It supports digital radiography workflows by integrating image capture, enhancement, and distribution functionalities. As classified under the Radiology advisory committee, this system is intended for use in hospital and clinical imaging departments. The device operates within the LLZ product code category, reflecting its role in radiologic imaging solutions.
This system is supplied as a software-based solution, requiring installation on compatible hardware platforms for operation. It is intended for single-use or multi-user environments, depending on the deployment configuration, though no explicit sterility or reusability is stated. The device is FDA-cleared under 510(k) K971965 (originally filed as K920950) and falls under the Traditional clearance pathway. No MRI safety or size-specific storage requirements are documented, though proper IT infrastructure and compliance with facility protocols are implied for optimal performance.
Frequently asked questions
What is the Philips EasyVision RAD Acquisition System used for?
The Philips EasyVision RAD Acquisition System is a software platform designed specifically for radiology applications. It enables the acquisition, processing, and analysis of diagnostic images, supporting digital radiography workflows. This includes integrating image capture, enhancement, and distribution functionalities to improve efficiency in hospital and clinical imaging departments.
How is the Philips EasyVision RAD Acquisition System supplied and installed?
The Philips EasyVision RAD Acquisition System is supplied as a software-based solution. It requires installation on compatible hardware platforms to function. The system is flexible for deployment in both single-user and multi-user environments, depending on the specific configuration of the facility.
Is the Philips EasyVision RAD Acquisition System sterile or reusable?
The Philips EasyVision RAD Acquisition System is a software-based solution and does not involve physical sterility or reusability in the traditional sense. Since it operates on hardware platforms, its usability depends on the deployment setup—whether it is accessed by one user or multiple users—and adherence to facility protocols for optimal performance.
What are the regulatory approvals for the Philips EasyVision RAD Acquisition System?
The Philips EasyVision RAD Acquisition System holds FDA clearance under the 510(k) pathway, specifically with clearance number K971965 (originally filed as K920950). It was classified under the Radiology advisory committee and falls under the Traditional clearance pathway, reflecting its role in radiologic imaging solutions.
Are there any specific storage requirements for the Philips EasyVision RAD Acquisition System?
The Philips EasyVision RAD Acquisition System does not have documented MRI safety or size-specific storage requirements. However, proper IT infrastructure and compliance with facility protocols are essential for optimal performance. The system relies on hardware compatibility and software installation, so storage considerations primarily involve maintaining the necessary hardware and network environment.
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: Philips EasyVision RAD Acquisition System Installation and Technical ..., PHILIPS EASYVISION (K920950) — FDA 510 (k) | Innolitics, Philips Easyvision - Philips Medical Systems | FDA Evidence Review, Philips Easyvision - Philips Medical Systems | FDA Evidence Review
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K971965 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems, Inc.
Sources (1)
- FDA 510(k) K971965 24 fields · synced Oct 1, 2026