{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Arterys Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/arterys-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/arterys-inc",
    "json_url": "https://devicerts.com/manufacturers/arterys-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/arterys-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "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/arterys-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": "Arterys Inc.",
    "url": "https://devicerts.com/manufacturers/arterys-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000001775"
      },
      {
        "label": "FDA FEI",
        "value": "3013306229"
      },
      {
        "label": "DUNS",
        "value": "078466835"
      }
    ],
    "summary": "Arterys Inc. is a medical device manufacturer based in the United States, with 17 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II; EU Class IIa) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 17,
    "devices_note": null,
    "certificates": 1,
    "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 GUDID",
        "devices": 9
      },
      {
        "registry": "FDA 510(k)",
        "devices": 7
      },
      {
        "registry": "EUDAMED",
        "devices": 1
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 16
      },
      {
        "class": "EU Class IIa",
        "devices": 1
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z11",
        "name": "Bioimaging and radiotherapy instruments",
        "url": "https://devicerts.com/categories/emdn/Z11",
        "devices": 1
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "Emergo Europe B.V.",
        "url": "https://devicerts.com/representatives/emergo-europe-bv-nl-ar-000000116",
        "country": "Netherlands"
      }
    ]
  },
  "devices": {
    "shown": 17,
    "total": 17,
    "all_devices_url": "https://devicerts.com/manufacturers/arterys-inc",
    "items": [
      {
        "name": "Arterys Oncology DL AOM4",
        "url": "https://devicerts.com/devices/arterys-oncology-dl-aom4",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Arterys Cardio DL CVM2",
        "url": "https://devicerts.com/devices/arterys-cardio-dl-cvm2-3acb6b4b",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Arterys MICA AMM7",
        "url": "https://devicerts.com/devices/arterys-mica-amm7",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tempus Pixel AMM7",
        "url": "https://devicerts.com/devices/tempus-pixel-amm7-d20ea9a3",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Arterys Cardio DL CVM2",
        "url": "https://devicerts.com/devices/arterys-cardio-dl-cvm2",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Arterys Viewer AVM3",
        "url": "https://devicerts.com/devices/arterys-viewer-avm3-ff336dc2",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Arterys MICA AMM5",
        "url": "https://devicerts.com/devices/arterys-mica-amm5",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Arterys MICA AMM6",
        "url": "https://devicerts.com/devices/arterys-mica-amm6",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Arterys Viewer AVM3",
        "url": "https://devicerts.com/devices/arterys-viewer-avm3",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Arterys MICA",
        "url": "https://devicerts.com/devices/arterys-mica-llz",
        "model_reference": "K182034",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2018-10-17",
        "open_recall": false
      },
      {
        "name": "Arterys Cardio DL",
        "url": "https://devicerts.com/devices/arterys-cardio-dl-llz",
        "model_reference": "K163253",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2017-01-05",
        "open_recall": false
      },
      {
        "name": "Arterys Viewer",
        "url": "https://devicerts.com/devices/arterys-viewer-llz",
        "model_reference": "K171544",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2017-07-18",
        "open_recall": false
      },
      {
        "name": "Arterys MICA",
        "url": "https://devicerts.com/devices/arterys-mica-qih-k203744",
        "model_reference": "K203744",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2022-03-14",
        "open_recall": false
      },
      {
        "name": "Arterys MICA",
        "url": "https://devicerts.com/devices/arterys-mica-qih",
        "model_reference": "K192437",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2020-03-25",
        "open_recall": false
      },
      {
        "name": "Arterys Oncology DL",
        "url": "https://devicerts.com/devices/arterys-oncology-dl-llz",
        "model_reference": "K173542",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2018-01-25",
        "open_recall": false
      },
      {
        "name": "Arterys Software v2.0",
        "url": "https://devicerts.com/devices/arterys-software-v2-0-llz",
        "model_reference": "K162513",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2016-10-28",
        "open_recall": false
      },
      {
        "name": "Tempus Pixel",
        "url": "https://devicerts.com/devices/tempus-pixel-amm7",
        "model_reference": "AMM7",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "MDR 730904",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "BSI Group The Netherlands B.V.",
      "issued": "2026-03-20",
      "expires": "2031-04-14",
      "status": "reissued",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}