{ "format": "devicerts.device.v1", "cite_as": "Rayvolve, Azmed Sas. deviCERTS medical device catalogue. https://devicerts.com/devices/rayvolve-qbs (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/rayvolve-qbs", "json_url": "https://devicerts.com/devices/rayvolve-qbs.json", "markdown_url": "https://devicerts.com/devices/rayvolve-qbs.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA 510(k)", "url": "https://open.fda.gov/apis/device/510k/" }, { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" }, { "registry": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed" } ], "registry_records_last_synced": "2026-10-06", "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/rayvolve-qbs", "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": "Rayvolve", "registry_name": "Rayvolve", "url": "https://devicerts.com/devices/rayvolve-qbs", "manufacturer": { "name": "Azmed Sas", "url": "https://devicerts.com/manufacturers/azmed-sas", "country": "France", "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": "Primary DI / UDI-DI", "values": [ { "value": "03770018071022", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K220164", "registries": [ "FDA 510(k)", "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "QBS" ], "emdn": [], "gmdn": [ { "code": "63386", "term": "X-ray image interpretive software" } ], "description": { "text": "Rayvolve is a Radiological Computer Assisted Detection/Diagnosis Software for Fracture, designed to assist radiologists in identifying and evaluating fractures in X-ray images. It leverages AI algorithms to enhance diagnostic accuracy and efficiency by highlighting potential fracture sites, reducing interpretation variability, and supporting clinical decision-making in musculoskeletal imaging.\n\nThe software is supplied as a digital solution for use in radiology departments, hospitals, and imaging centers. It operates on standard medical imaging workstations and requires no physical sterilization or single-use considerations, as it is a reusable, non-invasive digital tool. Compliance is ensured through FDA 510(k) clearance and MDR authorization, with registration numbers and product codes (QBS) confirming regulatory adherence. No MRI safety or physical size constraints apply, as it functions entirely within existing radiology IT infrastructure.", "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": "GUDID", "region": "United States", "type": "GUDID listing", "number": "03770018071022", "number_label": "UDI-DI", "device_udi_di": null, "date": "2024-03-18", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false }, { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K220164", "number_label": null, "device_udi_di": null, "date": "2022-06-02", "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": "Identity", "fields": [ { "label": "Generic name", "values": [ { "value": "X-ray image interpretive software", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Model / reference", "values": [ { "value": "2", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "03770018071022", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K220164", "registries": [ "FDA 510(k)", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "QBS", "registries": [ "FDA 510(k)", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "GMDN term", "values": [ { "value": "X-ray image interpretive software", "code": "63386", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class II", "registries": [ "FDA 510(k)", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Regulation", "values": [ { "value": "21 CFR Part 892.2090", "registries": [ "FDA 510(k)", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Advisory committee", "values": [ { "value": "Radiology", "registries": [ "FDA 510(k)" ] } ] }, { "label": "FDA decision", "values": [ { "value": "SESE", "registries": [ "FDA 510(k)" ] } ] }, { "label": "GUDID distribution status", "values": [ { "value": "In Commercial Distribution", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Lot / batch number", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Supplied sterile", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Single use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Implantable", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Prescription use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Over-the-counter", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Convenience kit", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Combination product", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "HCT/P", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Premarket exempt", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Serial number", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Expiration date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] } ] }