Regius RS-1000 Medical Image Processing Workstation
by Konica Minolta Medical & Graphic, Inc.
510(k) K051521
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051521 | Date28 Jun 2005 | 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- Withdrawn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 Regius RS-1000 is a medical image processing workstation designed for radiology applications. It processes and enhances digital images from computed radiography (CR) modalities, enabling radiographers to manage, review, and analyze diagnostic visuals. The system integrates with CR equipment via a LAN interface, facilitating seamless data transfer and workflow integration. Its display capabilities support both color and monochrome outputs, catering to varied diagnostic needs.
This workstation is supplied as a standalone device with a built-in hard disk for image storage, a keyboard and mouse for user input, and a LAN interface for network connectivity. It is intended for use in radiology departments and is classified as a Class II X-ray system under FDA regulations. The device was cleared under the 510(k) pathway in 2005 (K-number K051521) and is intended for single-user, non-sterile environments. No specific MRI safety or sterility requirements are noted in the regulatory data.
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Questions
AI-generated answers, 1 Oct 2026
What is the Regius RS-1000 designed for?
The Regius RS-1000 is a medical image processing workstation specifically designed for radiology applications. It processes and enhances digital images from computed radiography (CR) modalities, allowing radiographers to manage, review, and analyze diagnostic visuals efficiently. The system is built to integrate seamlessly with CR equipment via a LAN interface, improving workflow efficiency in radiology departments.
How is the Regius RS-1000 supplied and what does it include?
The Regius RS-1000 is supplied as a standalone device. It includes a built-in hard disk for image storage, a keyboard and mouse for user interaction, and a LAN interface for network connectivity. This configuration ensures it can operate independently while still allowing integration with other systems within a radiology department.
Is the Regius RS-1000 sterile or intended for single-use?
The Regius RS-1000 is not sterile and is intended for use in non-sterile environments only. It is designed as a single-user workstation, meaning it is meant to be operated by one individual at a time and does not require disposal after each use. The device’s non-sterile classification aligns with its role as a processing and display system rather than a patient-facing tool.
What display capabilities does the Regius RS-1000 support?
The Regius RS-1000 supports both color and monochrome display outputs, providing flexibility to meet varied diagnostic needs in radiology. This dual-support feature allows clinicians to view images in the most effective format for their specific analysis, whether for general radiography or specialized imaging tasks.
How does the Regius RS-1000 integrate with other systems?
The Regius RS-1000 integrates with CR equipment through a LAN interface, enabling seamless data transfer and workflow integration. This connectivity allows the workstation to receive digital images directly from CR systems, streamlining the process of image acquisition, processing, and review within a radiology department.