{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Scimage, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/scimage-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/scimage-inc",
    "json_url": "https://devicerts.com/manufacturers/scimage-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/scimage-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-15",
    "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/manufacturers/scimage-inc",
    "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."
  },
  "manufacturer": {
    "name": "Scimage, Inc.",
    "url": "https://devicerts.com/manufacturers/scimage-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "FDA applicant, unverified",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "FDA"
    ],
    "identifiers": [
      {
        "label": "FDA FEI",
        "value": "3000206530"
      },
      {
        "label": "DUNS",
        "value": "958220790"
      }
    ],
    "summary": "Scimage, Inc. is a medical device manufacturer, with 4 devices listed in FDA 510(k) and FDA GUDID (FDA Class II and I) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 4,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA 510(k)",
        "devices": 3
      },
      {
        "registry": "FDA GUDID",
        "devices": 1
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 3
      },
      {
        "class": "FDA Class I",
        "devices": 1
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 4,
    "total": 4,
    "all_devices_url": "https://devicerts.com/manufacturers/scimage-inc",
    "items": [
      {
        "name": "PicomEnterprise 3.x",
        "url": "https://devicerts.com/devices/picomenterprise-3-x",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Netra Workstation And Netramd Software",
        "url": "https://devicerts.com/devices/netra-workstation-and-netramd-software-llz",
        "model_reference": "K003484",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2001-01-19",
        "open_recall": false
      },
      {
        "name": "Netra Workstation System & Netra Md Software",
        "url": "https://devicerts.com/devices/netra-workstation-system-and-netra-md-software-lmd",
        "model_reference": "K960911",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1996-05-29",
        "open_recall": false
      },
      {
        "name": "Scimage Picomenterprise",
        "url": "https://devicerts.com/devices/scimage-picomenterprise-llz",
        "model_reference": "K073169",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2008-01-09",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}