{ "format": "devicerts.device.v1", "cite_as": "3mensio Workstation 10.4, Pie Medical Imaging B.V. deviCERTS medical device catalogue. https://devicerts.com/devices/3mensio-workstation-10-4 (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/3mensio-workstation-10-4", "json_url": "https://devicerts.com/devices/3mensio-workstation-10-4.json", "markdown_url": "https://devicerts.com/devices/3mensio-workstation-10-4.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" }, { "registry": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed" }, { "registry": "FDA recalls", "url": "https://open.fda.gov/apis/device/recall/" } ], "registry_records_last_synced": "2026-10-23", "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/3mensio-workstation-10-4", "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": "3mensio Workstation 10.4", "registry_name": "3mensio Workstation 10.4", "url": "https://devicerts.com/devices/3mensio-workstation-10-4", "manufacturer": { "name": "Pie Medical Imaging B.V.", "url": "https://devicerts.com/manufacturers/pie-medical-imaging-b-v", "country": null, "country_basis": null, "fda_registration_country": "Netherlands" }, "status": { "state": "active", "label": "Active", "detail": 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"status": "ongoing", "initiated": "2025-07-14", "reason": "When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage", "applies": "this device", "via": "K153736" } ], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "3mensio Workstation", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Radiology DICOM image processing application software", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Model / reference", "values": [ { "value": "10.4", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" 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