{
  "format": "devicerts.device.v1",
  "cite_as": "Stellar Imaging System, Guangdong Optomedic Technologies, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/stellar-imaging-system-gcj (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/stellar-imaging-system-gcj",
    "json_url": "https://devicerts.com/devices/stellar-imaging-system-gcj.json",
    "markdown_url": "https://devicerts.com/devices/stellar-imaging-system-gcj.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      }
    ],
    "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/stellar-imaging-system-gcj",
    "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": "Stellar Imaging System",
    "registry_name": "Stellar Imaging System",
    "url": "https://devicerts.com/devices/stellar-imaging-system-gcj",
    "manufacturer": {
      "name": "Guangdong Optomedic Technologies, Inc.",
      "url": "https://devicerts.com/manufacturers/fda-fei-3029968414",
      "country": "China",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K241530",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "GCJ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Stellar Imaging System is a 3D dual-channel optical endoscope designed for advanced gastrointestinal and urological imaging. It integrates optical technology to provide natural depth perception, enabling precise visualization of internal anatomical structures during procedures.\n\nThis system is supplied with configurable camera head options, including 4K resolution and multi-modal imaging capabilities such as white light (2D/3D), indocyanine green (ICG), and methylene blue (MB). It is intended for reusable use in clinical settings, supported by a dedicated cart accommodating 32-inch 4K monitors. The device holds FDA 510K clearance and MDR authorization.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "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": "K241530",
      "number_label": null,
      "device_udi_di": null,
      "date": "2024-08-07",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": null,
      "number_label": null,
      "device_udi_di": null,
      "date": null,
      "date_kind": null,
      "decision_code": null,
      "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": "K241530",
              "registries": [
                "FDA 510(k)"
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            }
          ]
        },
        {
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              "registries": [
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            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 876.1500",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Gastroenterology, Urology",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
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            }
          ]
        }
      ]
    }
  ]
}