{
  "format": "devicerts.device.v1",
  "cite_as": "BSD3543W, BONTECH Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/bsd3543w-mqb (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/bsd3543w-mqb",
    "json_url": "https://devicerts.com/devices/bsd3543w-mqb.json",
    "markdown_url": "https://devicerts.com/devices/bsd3543w-mqb.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/bsd3543w-mqb",
    "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": "BSD3543W",
    "registry_name": "BSD3543W",
    "url": "https://devicerts.com/devices/bsd3543w-mqb",
    "manufacturer": {
      "name": "BONTECH Co., Ltd.",
      "url": "https://devicerts.com/manufacturers/bontech-co-ltd",
      "country": "South Korea",
      "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": "K200787",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "MQB"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The BSD3543W is a Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II medical device designed for capturing high-resolution radiographic images. It employs digital technology to convert X-ray exposure into electronic signals, enabling real-time imaging for diagnostic radiology procedures. This imager is engineered to provide precise, high-quality visualisation of internal structures, supporting accurate medical assessments in clinical settings.\n\nThis device is intended for use in radiology departments and is supplied as a reusable medical instrument. It is cleared under FDA 510(k) regulation 892.1680 with a Substantially Equivalent (SESE) determination, authorised under K-number K200787. The BSD3543W operates within standard MRI safety guidelines for Class II devices and requires proper maintenance and calibration to ensure optimal performance. It is not single-use and must be cleaned and sterilised according to established protocols.",
      "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": "K200787",
      "number_label": null,
      "device_udi_di": null,
      "date": "2020-04-23",
      "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",
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            {
              "value": "K200787",
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            }
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        {
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    {
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        },
        {
          "label": "Regulation",
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            {
              "value": "21 CFR Part 892.1680",
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            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
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            }
          ]
        },
        {
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              "value": "SESE",
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          ]
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    }
  ]
}