{
  "format": "devicerts.device.v1",
  "cite_as": "RayPilot System, Micropos Medical AB. deviCERTS medical device catalogue. https://devicerts.com/devices/raypilot-system-iye (data as of 2026-11-15).",
  "source": {
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    "json_url": "https://devicerts.com/devices/raypilot-system-iye.json",
    "markdown_url": "https://devicerts.com/devices/raypilot-system-iye.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "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/raypilot-system-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": {
    "name": "RayPilot System",
    "registry_name": "RayPilot System",
    "url": "https://devicerts.com/devices/raypilot-system-iye",
    "manufacturer": {
      "name": "Micropos Medical AB",
      "url": "https://devicerts.com/manufacturers/micropos-medical-ab",
      "country": "Sweden",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K203722",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "IYE"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The RayPilot System is a real-time electromagnetic tracking device designed for use with linear accelerators in radiotherapy. It continuously monitors and tracks the position of internal anatomical structures, such as the prostate, during treatment sessions to ensure precise targeting and alignment with the radiation beam. This system is classified as a linear accelerator accessory and is intended for integration with existing radiotherapy equipment to enhance treatment accuracy in radiology settings.\n\nThe RayPilot System is supplied as a reusable medical device and is intended for use in clinical radiotherapy environments. It is not sterile at the time of shipment but is designed to be cleaned and reprocessed according to standard medical device protocols. The system operates in the electromagnetic spectrum and is compatible with MRI-safe environments, though specific MRI safety certifications should be verified per facility guidelines. Authorized for use in the United States under an FDA 510(k) clearance (K203722), the device adheres to regulatory standards for Class II medical devices under the FDA’s 892.5050 classification. Storage and handling follow manufacturer guidelines to maintain performance and safety.",
      "ai_generated": true,
      "generated_on": "2026-09-20",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K203722",
      "number_label": null,
      "device_udi_di": null,
      "date": "2021-09-02",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
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      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
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            {
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            }
          ]
        },
        {
          "label": "Regulation",
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            {
              "value": "21 CFR Part 892.5050",
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            }
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        {
          "label": "Advisory committee",
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            {
              "value": "Radiology",
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        }
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}