Identifiers
- 510(k) Number
- K181989 FDA 510(k)
- FDA Product Code
- IYE 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)
The MRIdian Linac System is a hybrid medical device combining a linear accelerator with an integrated 0.35 Tesla MRI scanner. It is classified as a Linear Accelerator, Medical, designed for radiotherapy applications. This system enables real-time imaging of soft tissue during treatment, facilitating precise delivery of radiation therapy while visualizing patient anatomy simultaneously.
The device is intended for use in radiation oncology settings and is supplied as a reusable, non-sterile system. It operates within MRI safety guidelines for a 0.35 Tesla magnetic field strength. The MRIdian Linac System holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of February 20, 2019. It is regulated under the classification of Class II (Device Class: 2) and falls under the regulatory number 892.5050.
Frequently asked questions
What is the MRIdian Linac System used for?
The MRIdian Linac System is designed for radiotherapy applications in radiation oncology. It integrates a linear accelerator with an integrated 0.35 Tesla MRI scanner to provide real-time imaging of soft tissue during treatment. This allows clinicians to visualize patient anatomy simultaneously while delivering radiation, ensuring precise and targeted therapy.
Is the MRIdian Linac System reusable or single-use?
The MRIdian Linac System is supplied as a reusable device. It is not intended for single-use, meaning it is designed to be cleaned, maintained, and used repeatedly in clinical settings under proper sterilization protocols. The system itself is non-sterile, so adherence to manufacturer guidelines for cleaning and maintenance is essential.
What magnetic field strength does the MRIdian Linac System operate under?
The MRIdian Linac System operates within MRI safety guidelines for a 0.35 Tesla magnetic field strength. This strength allows for real-time imaging during radiation therapy while ensuring compatibility with the linear accelerator for precise treatment delivery.
How is the MRIdian Linac System regulated?
The MRIdian Linac System holds FDA 510(k) clearance under the Traditional pathway, with a decision date of February 20, 2019. It is classified as a Class II medical device under regulatory number 892.5050, indicating it is subject to special controls to ensure its safety and effectiveness in radiotherapy applications.
What safety considerations should be taken for storage and use?
Since the MRIdian Linac System operates within a 0.35 Tesla magnetic field, storage and use must comply with MRI safety guidelines to prevent interference with other magnetic-sensitive equipment or materials. The system should be stored in a controlled environment, away from unauthorized access, and maintained according to the manufacturer’s instructions to ensure optimal performance and safety.
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: MRIdian A3i Advantage - ViewRay Systems, Inc., ViewRay - MRIdian® | Klinik und Poliklinik für Strahlentherapie und ..., ViewRay Systems, Inc. - Visibly Better, The First Low-Field MRI-Guided Radiation Therapy Hybrid Integrated ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181989 | Class II | Active |
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Manufacturer
- Manufacturer
- Viewray Incorporated
- FDA Applicant
- Viewray, Incorporated
Sources (1)
- FDA 510(k) K181989 24 fields · synced Oct 1, 2026