{
  "format": "devicerts.device.v1",
  "cite_as": "SEQUENCER, Impac Medical Systems, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/sequencer-iye-k913612 (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/sequencer-iye-k913612",
    "json_url": "https://devicerts.com/devices/sequencer-iye-k913612.json",
    "markdown_url": "https://devicerts.com/devices/sequencer-iye-k913612.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/sequencer-iye-k913612",
    "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": "SEQUENCER",
    "registry_name": "SEQUENCER",
    "url": "https://devicerts.com/devices/sequencer-iye-k913612",
    "manufacturer": {
      "name": "Impac Medical Systems, Inc.",
      "url": "https://devicerts.com/manufacturers/impac-medical-systems-inc",
      "country": "United States",
      "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": "K913612",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "IYE"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The SEQUENCER is a Class II medical device in the Radiology specialty, identified as an Accelerator, Linear, Medical device type. It received FDA 510(k) clearance under K913612 on December 19, 1991, as substantially equivalent to a predicate device.\n\nThe device is manufactured by Impac Medical Systems, Inc., located in Palo Alto, CA, and is used to facilitate the delivery of defined radiotherapy treatment plans. It is supplied as a non-sterile, reusable device for use in clinical radiology settings, with no indication of sterility, single-use status, or MRI safety provided in the data.",
      "ai_generated": true,
      "generated_on": "2026-09-24",
      "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": "K913612",
      "number_label": null,
      "device_udi_di": null,
      "date": "1991-12-19",
      "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": "K913612",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "IYE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.5050",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}