{ "format": "devicerts.device.v1", "cite_as": "LSN, Imaging Biometrics, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/lsn-jak (data as of 2026-11-14).", "source": { "canonical_url": "https://devicerts.com/devices/lsn-jak", "json_url": "https://devicerts.com/devices/lsn-jak.json", "markdown_url": "https://devicerts.com/devices/lsn-jak.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": "2026-11-14", "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/lsn-jak", "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": "LSN", "registry_name": "LSN", "url": "https://devicerts.com/devices/lsn-jak", "manufacturer": { "name": "Imaging Biometrics, LLC", "url": "https://devicerts.com/manufacturers/imaging-biometrics-llc", "country": "United States", "country_basis": null, "fda_registration_country": null }, "status": { "state": "active", "label": "Active", "detail": "European Union and United States" }, "classification": [ { "class": "Class I", "system": "EU MDD" }, { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "D-B319LSN10JD", "registries": [ "EUDAMED" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-B319LSN10JD", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K201092", "registries": [ "FDA 510(k)" ] } ] } ], "product_codes": [ "JAK" ], "emdn": [ { "code": "Z11069092", "term": "VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE" } ], "gmdn": [], "description": { "text": "The LSN is a Medical Image Processing Device (FDA Product Code JAK) designed for the analysis and quantification of radiological images, specifically for brain tumor characterization. It processes imaging data to provide objective measurements and metrics that assist in diagnostic and treatment planning workflows.\n\nThis device is supplied as software and operates within a clinical radiology setting, requiring integration with existing imaging systems for data input. It is intended for single-use per imaging session, with no sterility requirements, and is classified as non-MRI conditional. Authorisations include FDA 510(k) clearance under the Medical Devices Directive (MDD) and are applicable in the United States. No third-party reprocessing is permitted.", "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": "EUDAMED", "region": "European Union", "type": "CE/MDD", "number": "B-B319LSN10JD", "number_label": "Basic UDI-DI", "device_udi_di": "D-B319LSN10JD", "date": "2023-02-27", "date_kind": "registered", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K201092", "number_label": null, "device_udi_di": null, "date": "2020-10-29", "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": "Identity", "fields": [ { "label": "Model / reference", "values": [ { "value": "LSN", "registries": [ "EUDAMED" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "D-B319LSN10JD", "registries": [ "EUDAMED" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-B319LSN10JD", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K201092", "registries": [ "FDA 510(k)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "JAK", "registries": [ "FDA 510(k)" ] } ] }, { "label": "EMDN code", "values": [ { "value": "Z11069092", "registries": [ "EUDAMED" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class I", "registries": [ "EUDAMED" ] }, { "value": "Class II", "registries": [ "FDA 510(k)" ] } ] }, { "label": "Regulation", "values": [ { "value": "21 CFR Part 892.1750", "registries": [ "FDA 510(k)" ] } ] }, { "label": "EU registration type", "values": [ { "value": "Legacy device (under a directive)", "registries": [ "EUDAMED" ] } ] }, { "label": "EU market of registration", "values": [ { "value": "Italy", "registries": [ "EUDAMED" ] } ] }, { "label": "Advisory committee", "values": [ { "value": "Radiology", "registries": [ "FDA 510(k)" ] } ] }, { "label": "FDA decision", "values": [ { "value": "SESE", "registries": [ "FDA 510(k)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Supplied sterile", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Implantable", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Reusable", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Reprocessed single-use device", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a substance derived from human blood or plasma", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains human tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains animal tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Administering medicine", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Measuring function", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a medicinal substance", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] } ] } ] }