{
  "format": "devicerts.device.v1",
  "cite_as": "Flaatz 760, Drtech Corp. deviCERTS medical device catalogue. https://devicerts.com/devices/flaatz-760-kpr (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/flaatz-760-kpr",
    "json_url": "https://devicerts.com/devices/flaatz-760-kpr.json",
    "markdown_url": "https://devicerts.com/devices/flaatz-760-kpr.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
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    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-14",
    "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/flaatz-760-kpr",
    "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": "Flaatz 760",
    "registry_name": "FLAATZ 760",
    "url": "https://devicerts.com/devices/flaatz-760-kpr",
    "manufacturer": {
      "name": "Drtech Corp.",
      "url": "https://devicerts.com/manufacturers/drtech-corp",
      "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": "K111655",
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        ]
      }
    ],
    "product_codes": [
      "KPR"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Flaatz 760 is a stationary X-ray system flat panel detector, designed for high-volume radiography applications. It features a radiography flat panel detector with advanced temperature stability and uniform coating technology to ensure consistent image quality even after extensive use.\n\nThis device is intended for use in radiology settings and is supplied as a reusable, non-sterile medical device. It is classified as a Class II device under FDA regulations (21 CFR 892.1680) and holds a Special 510(k) clearance (K111655) with a decision date of November 30, 2011. The device is MRI-unsafe and requires proper storage and handling as specified by the manufacturer.",
      "ai_generated": true,
      "generated_on": "2026-09-19",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
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  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K111655",
      "number_label": null,
      "device_udi_di": null,
      "date": "2011-11-30",
      "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": [
    {
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        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K111655",
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            }
          ]
        },
        {
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            {
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            }
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        },
        {
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    }
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}