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AlignRT Plus (8.0)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K253012

by Vision RT Ltd.

Identifiers

510(k) Number
K253012 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 AlignRT Plus (8.0) is a linear accelerator system designed for precise radiation therapy delivery in oncology. It integrates advanced imaging and real-time tracking technologies to ensure accurate targeting of tumours while minimising exposure to surrounding healthy tissue, supporting both external beam radiotherapy and stereotactic ablative radiotherapy (SABR).

This device is supplied as a reusable medical system, intended for use in hospital-based radiation oncology departments. It operates within MRI-safe environments and is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR). The system requires specialised training for operation and maintenance, with components subject to routine calibration and servicing as per manufacturer guidelines. Authorisations include FDA_510K and MDR compliance, ensuring adherence to stringent safety and performance standards.

Frequently asked questions

What types of radiation therapy can the AlignRT Plus (8.0) be used for, and how does it improve precision?

The AlignRT Plus (8.0) is designed for both external beam radiotherapy and stereotactic ablative radiotherapy (SABR). It integrates advanced imaging and real-time tracking technologies to ensure precise tumour targeting while minimising exposure to surrounding healthy tissue. This reduces the risk of complications and improves treatment accuracy by dynamically adjusting to patient movement or anatomical changes during therapy.

Is the AlignRT Plus (8.0) a single-use or reusable device, and what maintenance does it require?

The AlignRT Plus (8.0) is a reusable medical system intended for hospital-based radiation oncology departments. Due to its complexity, it requires specialised training for operation and maintenance. Components must undergo routine calibration and servicing as per manufacturer guidelines to ensure optimal performance and safety.

Can the AlignRT Plus (8.0) be used in environments where MRI equipment is present, and what regulatory approvals does it hold?

Yes, the AlignRT Plus (8.0) is designed to operate within MRI-safe environments. It holds FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR), ensuring it meets stringent safety and performance standards for use in radiation therapy settings.

What kind of facility or department would typically use the AlignRT Plus (8.0), and why is it suited for that environment?

The AlignRT Plus (8.0) is intended for hospital-based radiation oncology departments, particularly those specialising in advanced cancer treatments. Its integration of real-time tracking and imaging technologies makes it ideal for high-precision radiotherapy, including complex cases like SABR, where accuracy and adaptability are critical. The system’s compatibility with MRI-safe environments also aligns with modern oncology facilities that combine multiple imaging modalities.

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

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vision RT Ltd.
FDA Applicant
Vision Rt, Ltd.

Sources (2)

  • FDA 510(k) K253012 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026