{"id":"2b2c3dfa-2849-4673-bd6d-b6470de16c14","slug":"epione-fda-510k-2022","filingNumber":null,"filingType":"fda_510k","jurisdiction":"us_fda","applicantCompanyId":"cb6a0ecc-6b4d-486d-9356-ea9c928ba0ed","filingDate":"2022-03-22T00:00:00.000Z","decisionDate":"2022-03-22T00:00:00.000Z","status":"cleared","clearanceScope":"FDA 510(k) clearance for Epione robot for cancer treatment (abdominal ablation). CE Mark for abdomen, chest, and musculoskeletal.","sources":[{"url":"https://www.quantumsurgical.com/news/quantum-surgical-receives-fda-510k-clearance-for-the-epione-robot-designed-for-cancer-treatment","title":"Epione FDA 510(k)","sourceName":"Quantum Surgical"}],"verificationPosture":"verified","capFlagNotes":"FDA for abdominal. CE Mark broader scope.","relatedIncidentId":null,"reviewStatus":"unreviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-07-15T02:42:52.579Z","updatedAt":"2026-07-15T02:42:52.579Z","applicantCompany":{"id":"cb6a0ecc-6b4d-486d-9356-ea9c928ba0ed","slug":"quantum-surgical","name":"Quantum Surgical"},"modelLinks":[{"id":"c0c89622-0d98-40ed-8d23-6155c27cf698","modelId":"ba28973f-6a33-4cce-a22f-d34a99443937","regulatoryFilingId":"2b2c3dfa-2849-4673-bd6d-b6470de16c14","createdAt":"2026-07-15T02:42:53.508Z","model":{"slug":"epione","modelName":"Epione"}}]}