{
  "format": "devicerts.device.v1",
  "cite_as": "AlignRT Plus (8.0), Vision RT Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/alignrt-plus-8-0-iye (data as of 2026-11-14).",
  "source": {
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    "markdown_url": "https://devicerts.com/devices/alignrt-plus-8-0-iye.md",
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    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/alignrt-plus-8-0-iye",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
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    "registry_name": "AlignRT Plus (8.0)",
    "url": "https://devicerts.com/devices/alignrt-plus-8-0-iye",
    "manufacturer": {
      "name": "Vision RT Ltd.",
      "url": "https://devicerts.com/manufacturers/vision-rt-ltd",
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    ],
    "product_codes": [
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    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "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).\n\nThis 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.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
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    {
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