(46 days)
RayCare is an oncology information system used to support workflows, scheduling and clinical information management for oncology care and follow-up. RayCare may be used in the transfer, storage, conversion and display of patient data in all areas of cancer care including radiation therapy, medical oncology and surgical oncology. RayCare is not intended for use in diagnostic activities.
RayCare is an oncology information system that supports healthcare professionals in managing cancer care. The system is structured in functionality modules that are listed below. RayCare is a software-only system with a client part that allows the user to interact with the system and a server part that performs the necessary processing and storage functions. Selected aspects of RayCare are configurable, such as adapting workflow templates to the specific needs of the clinic.
- Patient clinical data
- Care administration
- Clinical notes and documents
- Workflow and task management
- Charge capture
- Scheduling and calendar functions
- PACS
- Image viewer
- Simulation and imaging
- System administration
- Authentication, authorization and audit logging
- Hospital system integrations
The provided text is a 510(k) summary for the RayCare 2.3 device. It describes the device, its intended use, and its technological characteristics. However, it does not provide specific acceptance criteria or a detailed study proving the device meets those criteria with performance metrics.
The document states that "The verification and validation of RayCare 2.3 is based on the intended use and functionalities included in a standard oncology information system, and on the standards ISO 14971, IEC 61217, IEC 62304 and IEC 62366. The successful verification and validation of RayCare 2.3 therefore support the substantial equivalence to the MOSAIQ Oncology Information System predicate device."
This indicates that the device's performance was assessed against its intended use and relevant industry standards, demonstrating "substantial equivalence" to a predicate device (MOSAIQ Oncology Information System) rather than meeting specific, quantitative acceptance criteria with reported data.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval through substantial equivalence, which does not typically include the level of detail regarding acceptance criteria and performance studies that would be found in a clinical trial report or a more comprehensive technical document.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.