[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NYI":3},{"classification":4,"mappedDevices":45,"similarCandidates":46,"relatedClassifications":129,"syncDates":140},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":39,"updated_at":40,"recall_count":41,"latest_recall_date":42,"k510_count":43,"pma_count":44,"event_count":41},1759,"NYI","Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer","2","866.6040","IM","Immunology","PA","1","A device which uses a gene expression profile of a breast cancer tumor, from patients stage i or stage ii lymph node negative, with a tumor size of \u003C5.0 cm, to provide a risk assessment for distant recurrence of breast cancer.  The result is indicated for use only as a prognostic marker by physicians along with a number of other factors to assess the risk of recurrence of breast cancer.",false,{"openfda":17,"definition":14,"device_name":7,"review_code":36,"device_class":8,"implant_flag":37,"product_code":6,"review_panel":12,"gmp_exempt_flag":37,"third_party_flag":37,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":36,"life_sustain_support_flag":37,"medical_specialty_description":11,"summary_malfunction_reporting":38},{"k_number":18,"fei_number":29,"registration_number":34},[19,20,21,22,23,24,25,26,27,28],"DEN070009","K141771","K210973","K070675","K141142","K101454","K080252","K201902","K081092","K130010",[30,31,32,33],"3017845262","3004185580","3039487170","3007297853",[30,32,33,35],"2032839","","N","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-18T22:05:38.961415+00:00",1,null,10,0,[],[47,56,64,72,81,89,97,105,113,121],{"medical_device_id":48,"generic_name":49,"class_classification":50,"jmdn_code":51,"name_similarity":52,"definition_similarity":53,"vector_similarity":54,"score":55},1157,"遺伝子変異解析システム（がんゲノムプロファイリング検査用）","Ⅲ","60943033",0.140351,0.225434,0.705445,0.031754,{"medical_device_id":57,"generic_name":58,"class_classification":50,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},1147,"遺伝子変異解析セット（がんゲノムプロファイリング検査用）","60943013",0.144144,0.198083,0.703752,0.0312576,{"medical_device_id":65,"generic_name":66,"class_classification":50,"jmdn_code":67,"name_similarity":68,"definition_similarity":69,"vector_similarity":70,"score":71},1151,"遺伝子変異解析プログラム（がんゲノムプロファイリング検査用）","60943023",0.137931,0.223242,0.695596,0.0307765,{"medical_device_id":73,"generic_name":74,"class_classification":75,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":80},3279,"胸部画像診断・放射線治療用患者体位固定具","Ⅰ","40899000",0.16,0.208333,0.650742,0.0301587,{"medical_device_id":82,"generic_name":83,"class_classification":50,"jmdn_code":84,"name_similarity":85,"definition_similarity":86,"vector_similarity":87,"score":88},1140,"体細胞遺伝子変異解析システム（抗悪性腫瘍薬適応判定用）","71059003",0.118056,0.214477,0.664089,0.0275797,{"medical_device_id":90,"generic_name":91,"class_classification":50,"jmdn_code":92,"name_similarity":93,"definition_similarity":94,"vector_similarity":95,"score":96},1153,"体細胞遺伝子変異解析プログラム（抗悪性腫瘍薬適応判定用）","70159013",0.117241,0.227405,0.657936,0.0273641,{"medical_device_id":98,"generic_name":99,"class_classification":50,"jmdn_code":100,"name_similarity":101,"definition_similarity":102,"vector_similarity":103,"score":104},1165,"体細胞遺伝子変異解析セット（抗悪性腫瘍薬適応判定用）","71059023",0.120567,0.194767,0.656673,0.0262575,{"medical_device_id":106,"generic_name":107,"class_classification":50,"jmdn_code":108,"name_similarity":109,"definition_similarity":110,"vector_similarity":111,"score":112},1139,"生殖細胞系列遺伝子変異解析プログラム（抗悪性腫瘍薬適応判定用）","71058003",0.111888,0.246377,0.648179,0.0254481,{"medical_device_id":114,"generic_name":115,"class_classification":50,"jmdn_code":116,"name_similarity":117,"definition_similarity":118,"vector_similarity":119,"score":120},1162,"生殖細胞系列遺伝子変異解析プログラム（罹患リスク判定用）","71058013",0.113636,0.236686,0.632612,0.0247858,{"medical_device_id":122,"generic_name":123,"class_classification":50,"jmdn_code":124,"name_similarity":125,"definition_similarity":126,"vector_similarity":127,"score":128},1184,"腫瘍悪性度判定支援プログラム","61231003",0.056,0.240122,0.711824,0.0163934,[130,134,137],{"product_code":131,"device_name":132,"device_class":8,"k510_count":133},"OVQ","Chronic Lymphocytic Leukemia Fish Probe Kit",2,{"product_code":135,"device_name":136,"device_class":8,"k510_count":41},"OWK","Early Growth Response 1 (Egr) Fish Probe Kit",{"product_code":138,"device_name":139,"device_class":8,"k510_count":41},"OWM","Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers",{"510k":141,"classification":142,"enforcement":143,"event":144,"pma":145,"warning_letter":146},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]