{
  "format": "devicerts.device.v1",
  "cite_as": "Accuvue+, Radmedix, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/accuvue-mqb (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/accuvue-mqb",
    "json_url": "https://devicerts.com/devices/accuvue-mqb.json",
    "markdown_url": "https://devicerts.com/devices/accuvue-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/accuvue-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": "Accuvue+",
    "registry_name": "Accuvue+",
    "url": "https://devicerts.com/devices/accuvue-mqb",
    "manufacturer": {
      "name": "Radmedix, LLC",
      "url": "https://devicerts.com/manufacturers/radmedix-llc",
      "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": "K201058",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "MQB"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "Accuvue+ is a Solid State X-Ray Imager (Flat Panel/Digital Imager) used in radiology. It is a software application designed to facilitate the management, distribution, and viewing of radiological digital imaging and communications in medicine (DICOM) image data, including functions for viewing, communication, printing, recording or disc burning, and image manipulation.\n\nThe device is supplied as a software application and is authorized under FDA 510(k) clearance (K201058). It is substantially equivalent to a predicate device and is intended for use in radiological imaging workflows. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or specific clinical settings is provided in the data.",
      "ai_generated": true,
      "generated_on": "2026-09-27",
      "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": "K201058",
      "number_label": null,
      "device_udi_di": null,
      "date": "2020-05-06",
      "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": "K201058",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "MQB",
              "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 892.1680",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}