Identifiers
- 510(k) Number
- K191384 FDA 510(k)
- FDA Product Code
- MUJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
RayCare 2.3 is an oncology information system designed for workflow management, scheduling, and clinical data handling in radiation therapy and oncology. It facilitates the transfer, storage, conversion, and display of patient data, supporting comprehensive cancer care workflows. The system integrates with radiation therapy planning and treatment processes to enhance clinical efficiency and coordination.
RayCare 2.3 is supplied as software and operates in clinical settings such as radiation oncology departments and cancer care centers. It is intended for use with compatible hardware and may be integrated into existing IT infrastructures. The device holds FDA 510(k) clearance (K191384) under the Radiology advisory committee and is classified as a Class II medical device under regulation 892.5050. No sterility or single-use/reusable specifications are noted; compatibility with MRI environments is not addressed in the data.
Frequently asked questions
What is the RayCare 2.3 system designed for?
The RayCare 2.3 is an oncology information system specifically designed to manage workflows in radiation therapy and cancer care. It supports tasks such as scheduling, clinical data handling, and seamless transfer and storage of patient information. By integrating with radiation therapy planning and treatment processes, it helps improve coordination and efficiency in clinical settings like radiation oncology departments and cancer care centers.
How is the RayCare 2.3 system supplied and where is it used?
RayCare 2.3 is supplied exclusively as software and is intended for use in clinical environments such as radiation oncology departments and cancer care centers. It operates on compatible hardware and can be integrated into existing IT infrastructures to support comprehensive cancer care workflows.
Is the RayCare 2.3 system single-use or reusable?
The RayCare 2.3 system is not a physical device requiring sterility or single-use considerations. As software, it is designed for repeated use within clinical settings, with updates and maintenance provided by the manufacturer to ensure ongoing functionality and compliance with regulatory standards.
What regulatory approval does the RayCare 2.3 system hold?
The RayCare 2.3 system holds FDA 510(k) clearance under the Radiology advisory committee, classified as a Class II medical device under regulation 892.5050. This clearance indicates that the system has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets applicable safety and performance standards for radiation therapy workflow management.
Can the RayCare 2.3 system be integrated with other medical devices or systems?
Yes, the RayCare 2.3 system is designed to integrate with existing IT infrastructures and compatible hardware, particularly within radiation therapy planning and treatment processes. This integration capability enhances clinical efficiency by enabling seamless data transfer, storage, and display across different systems used in cancer care 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. Sources consulted: Software in radiation therapy and oncology | RaySearch Laboratories, RayCare 2.3 by RaySearch Laboratories AB (publ) | FDA 510(k) Summary, The next-generation oncology information system - RayCare | RaySearch ..., RayCare 2.3 | RaySearch Laboratories AB (publ) | Aletia Index
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191384 | Class II | Active |
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Manufacturer
- Manufacturer
- RaySearch Laboratories AB (PUBL)
Sources (1)
- FDA 510(k) K191384 24 fields · synced Oct 1, 2026