{
  "format": "devicerts.device.v1",
  "cite_as": "Clarius Bladder AI, Clarius Mobile Health Corp. deviCERTS medical device catalogue. https://devicerts.com/devices/clarius-bladder-ai-qih (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/clarius-bladder-ai-qih",
    "json_url": "https://devicerts.com/devices/clarius-bladder-ai-qih.json",
    "markdown_url": "https://devicerts.com/devices/clarius-bladder-ai-qih.md",
    "publisher": "deviCERTS (devicerts.com)",
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        "url": "https://open.fda.gov/apis/device/510k/"
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    "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/clarius-bladder-ai-qih",
    "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": "Clarius Bladder AI",
    "registry_name": "Clarius Bladder AI",
    "url": "https://devicerts.com/devices/clarius-bladder-ai-qih",
    "manufacturer": {
      "name": "Clarius Mobile Health Corp.",
      "url": "https://devicerts.com/manufacturers/fda-fei-3012747207",
      "country": "Canada",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
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      }
    ],
    "product_codes": [
      "QIH"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "Clarius Bladder AI is a noninvasive tool designed to automatically measure bladder volume. It identifies and highlights the bladder to deliver calculations that support clinical decision-making and interventions.\n\nThis device has received 510(k) clearance from the U.S. FDA. It is intended for use in settings such as hospitals, clinics, and nursing homes to assist in the assessment of bladder volume.",
      "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."
    },
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      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K232257",
      "number_label": null,
      "device_udi_di": null,
      "date": "2023-11-13",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
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  "eu_market_availability": null,
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}