{
  "format": "devicerts.device.v1",
  "cite_as": "True Definition DL, GE Healthcare Japan Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/true-definition-dl-jak (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/true-definition-dl-jak",
    "json_url": "https://devicerts.com/devices/true-definition-dl-jak.json",
    "markdown_url": "https://devicerts.com/devices/true-definition-dl-jak.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/true-definition-dl-jak",
    "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": "True Definition DL",
    "registry_name": "True Definition DL",
    "url": "https://devicerts.com/devices/true-definition-dl-jak",
    "manufacturer": {
      "name": "GE Healthcare Japan Corporation",
      "url": "https://devicerts.com/manufacturers/fda-fei-3002808529",
      "country": "Japan",
      "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": "K253686",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "JAK"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The True Definition DL is a deep-learning CT reconstruction function that enhances high-contrast spatial resolution for bone and lung imaging on compatible CT systems. It is a Class 2 Radiology device with product code JAK. The device is used for radiology applications, specifically for CT reconstruction. It is designed to improve image quality for certain types of imaging.\n\nThe True Definition DL is supplied by GE Healthcare Japan Corporation and has received FDA 510(k) clearance. It is a non-third-party device, cleared through the Traditional 510(k) pathway. The device has a specific product code, JAK, and is associated with the k number K253686. It is intended for use in radiology settings, including for bone and lung imaging on compatible CT systems.",
      "ai_generated": true,
      "generated_on": "2026-09-26",
      "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": "K253686",
      "number_label": null,
      "device_udi_di": null,
      "date": "2026-03-23",
      "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": "K253686",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "JAK",
              "registries": [
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            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.1750",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
              "registries": [
                "FDA 510(k)"
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            }
          ]
        },
        {
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          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}