Philips EasyVision Workstation
by Philips Medical Systems North America, Inc. 2 variants
510(k) K974207
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974207 | Date22 Jan 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Philips EasyVision Workstation is a diagnostic imaging workstation designed for processing, viewing, and managing medical images. As a radiology device, it facilitates the interpretation and analysis of radiographic studies, enabling clinicians to assess and diagnose conditions based on visual data. Its functionality aligns with the needs of radiology departments for efficient image handling and archiving.
The workstation is supplied as a reusable, non-sterile device intended for use in clinical radiology settings. It is cleared for use under FDA 510(k) authorization (K974207) and falls under the product code LLZ, classified as a Class 2 device. Storage and maintenance follow manufacturer guidelines to ensure proper functionality, with no specific MRI safety restrictions noted in the regulatory data.
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Questions
AI-generated answers, 1 Oct 2026
What is the Philips EasyVision Workstation used for?
The Philips EasyVision Workstation is designed specifically for radiology departments to process, view, and manage medical images. It helps clinicians interpret radiographic studies, such as X-rays, CT scans, or MRIs, by providing tools for detailed analysis and diagnosis. This reduces manual effort and improves workflow efficiency in interpreting visual diagnostic data.
Is the Philips EasyVision Workstation reusable or single-use?
The Philips EasyVision Workstation is a reusable device, meaning it is intended for repeated use in clinical radiology settings. Unlike single-use devices, it is built to withstand regular maintenance and cleaning protocols to ensure long-term functionality and reliability in diagnostic workflows.
What are the key storage and maintenance requirements for this workstation?
The Philips EasyVision Workstation requires adherence to manufacturer guidelines for storage and maintenance to ensure optimal performance. While no specific MRI safety restrictions are noted, proper environmental conditions (e.g., temperature, humidity) and regular upkeep—such as software updates and hardware inspections—are critical. Follow Philips’ operational manuals to avoid degradation or malfunctions.
Does this workstation have any regulatory approvals or classifications?
The Philips EasyVision Workstation holds FDA 510(k) clearance under the reference number K974207, classified as a Class 2 device under product code LLZ. This designation indicates it is substantially equivalent to a legally marketed predicate device and meets U.S. regulatory standards for radiology imaging workstations.
Can this workstation integrate with other imaging systems or PACS?
While the provided data does not explicitly detail integration capabilities, the Philips EasyVision Workstation is designed for compatibility with standard radiology workflows. Many similar workstations in this category support interoperability with Picture Archiving and Communication Systems (PACS) or other imaging modalities. For specific compatibility, consult Philips’ technical documentation or support resources.