PowerServer, PowerReader, Gateway and PowerCache
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Ramsoft Inc
Identifiers
- 510(k) Number
- K052460 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)
This device is a Radiology Information System Workstation (Product Code: LLZ) designed to manage, process, and display digital medical imaging data. It integrates with Picture Archiving and Communication Systems (PACS) to enable radiologists and clinicians to view, store, and retrieve diagnostic images efficiently, supporting workflows in radiology departments.
The system is supplied as a software-hardware combination, intended for use in radiology settings where digital imaging is processed. It is not described as single-use or reusable, and no sterility or MRI safety information is provided. Authorisations include FDA 510K clearance under the Traditional pathway and MDD compliance, with no explicit details on sterility, single-use, or regulatory status beyond the stated approvals.
Frequently asked questions
What types of medical imaging data can the POWERSERVER system manage and display, and how does it integrate with existing systems in a radiology department?
The POWERSERVER system is designed to manage, process, and display digital medical imaging data, including all formats used in radiology workflows. It integrates directly with Picture Archiving and Communication Systems (PACS) to enable seamless viewing, storage, and retrieval of diagnostic images by radiologists and clinicians. This integration streamlines workflows by centralizing image access and analysis in radiology departments.
Is the POWERSERVER system a standalone software solution or does it require specific hardware components, and how is it supplied?
The POWERSERVER system is supplied as a software-hardware combination, meaning it includes both the necessary computational hardware and the software application required for operation. It is not described as a purely software-only solution, so hardware components are integral to its functionality. The system is intended for use in radiology settings where digital imaging data needs to be processed and displayed.
How does the POWERSERVER system differ from other radiology workstations, and what regulatory pathways has it undergone?
Unlike some radiology workstations that may focus solely on image viewing, the POWERSERVER system is designed to manage, process, and display digital imaging data while integrating with PACS. This makes it particularly suited for environments requiring centralized image workflows. Regulatory-wise, it has received FDA 510(k) clearance under the Traditional pathway and complies with the MDD (Medical Device Directive), ensuring it meets established safety and performance standards for radiology information systems.
What is the intended clinical environment for the POWERSERVER system, and does it have any special considerations for setup or compatibility?
The POWERSERVER system is intended for use in radiology departments where digital imaging is processed, such as hospitals, diagnostic imaging centers, or large medical facilities. Since it integrates with PACS, compatibility depends on the existing infrastructure—specifically, the PACS system must support its connectivity protocols. No special considerations like sterility or MRI safety are mentioned, as it is a non-invasive, software-hardware system for diagnostic workflows.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K052460 | Class II | Active |
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Manufacturer
- Manufacturer
- Ramsoft Inc
- FDA Applicant
- Ramsoft, Inc.
Sources (2)
- FDA 510(k) K052460 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026