{
  "format": "devicerts.device.v1",
  "cite_as": "Iplan, Brainlab AG. deviCERTS medical device catalogue. https://devicerts.com/devices/iplan-haw-k053127 (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/iplan-haw-k053127",
    "json_url": "https://devicerts.com/devices/iplan-haw-k053127.json",
    "markdown_url": "https://devicerts.com/devices/iplan-haw-k053127.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/iplan-haw-k053127",
    "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": "Iplan",
    "registry_name": "IPLAN",
    "url": "https://devicerts.com/devices/iplan-haw-k053127",
    "manufacturer": {
      "name": "Brainlab AG",
      "url": "https://devicerts.com/manufacturers/brainlab-ag",
      "country": null,
      "country_basis": null,
      "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": "K053127",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "HAW"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The iPlan Performance is a planning and treatment transfer system for radiotherapy and neurosurgical applications, designed to facilitate precise treatment planning and adaptive radiotherapy workflows. It integrates advanced imaging, planning, and simulation tools to support complex treatment strategies, including stereotactic radiosurgery and fractionated radiotherapy. The system automates plan adjustments to accommodate anatomical changes, ensuring adaptive and dynamic treatment optimization. It is part of Brainlab’s iPlan suite, which emphasizes integration with existing clinical workflows and imaging modalities.\n\nThis system is supplied as software installed on a desktop platform, requiring compatible hardware and operating systems for operation. It is intended for use in radiation oncology departments and neurosurgical settings, where it interfaces with CT, MRI, and other imaging systems. The device is not single-use; it is designed for repeated use within a clinical environment, with updates and maintenance provided by the manufacturer. Regulatory clearance under FDA 510K (K053127) confirms its compliance with U.S. medical device standards, though specific sterility or MRI safety classifications are not detailed in the provided data.",
      "ai_generated": true,
      "generated_on": "2026-10-01",
      "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": "K053127",
      "number_label": null,
      "device_udi_di": null,
      "date": "2006-02-09",
      "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": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K053127",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
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            {
              "value": "HAW",
              "registries": [
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            }
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    },
    {
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      "fields": [
        {
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            {
              "value": "Class II",
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              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 882.4560",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Neurology",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
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            }
          ]
        }
      ]
    }
  ]
}