{
  "format": "devicerts.device.v1",
  "cite_as": "ImageGrid Radiology Viewer System, Candelis, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/imagegrid-radiology-viewer-system-llz (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/imagegrid-radiology-viewer-system-llz",
    "json_url": "https://devicerts.com/devices/imagegrid-radiology-viewer-system-llz.json",
    "markdown_url": "https://devicerts.com/devices/imagegrid-radiology-viewer-system-llz.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/imagegrid-radiology-viewer-system-llz",
    "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": "ImageGrid Radiology Viewer System",
    "registry_name": "IMAGEGRID RADIOLOGY VIEWER SYSTEM",
    "url": "https://devicerts.com/devices/imagegrid-radiology-viewer-system-llz",
    "manufacturer": {
      "name": "Candelis, Inc.",
      "url": "https://devicerts.com/manufacturers/candelis-inc",
      "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": "K092949",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "LLZ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The ImageGrid Radiology Viewer System is a medical imaging device designed for the reception, storage, communication, and display of digital medical images and data from various imaging modalities. It functions as a Picture Archiving and Communication System (PACS) to facilitate workflow optimization, enabling radiologists and clinicians to view, analyze, and share images across distributed networks.\n\nThis system is supplied as software and integrates with existing IT infrastructure to route, store, and present DICOM-compatible medical images. It is intended for use in radiology departments and clinical settings, where pre-processed DICOM presentation images—including mammography—can be interpreted for diagnostic purposes. The device is classified under FDA 510(k) clearance (K092949) with a traditional review pathway and is intended for single-use or multi-user networked environments, though sterility and reuse specifications are not explicitly detailed in the data.",
      "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."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K092949",
      "number_label": null,
      "device_udi_di": null,
      "date": "2009-10-08",
      "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": "K092949",
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              "value": "Class II",
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.2050",
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            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
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            }
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  ]
}