[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NBK":3},{"classification":4,"mappedDevices":28,"similarCandidates":29,"relatedClassifications":102,"syncDates":163},{"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":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":26,"pma_count":24,"event_count":27},5506,"NBK","System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer","2","864.1860","HE","Hematology","PA","1","",false,{"openfda":17,"definition":14,"device_name":7,"review_code":14,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":12,"gmp_exempt_flag":20,"third_party_flag":20,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":14,"life_sustain_support_flag":20,"medical_specialty_description":11,"summary_malfunction_reporting":21},{"k_number":18},[19],"K994356","N","Eligible","2026-08-18T05:52:52.949882+00:00","2026-08-18T22:05:38.961415+00:00",0,null,1,5,[],[30,38,45,52,59,67,74,81,88,95],{"medical_device_id":31,"generic_name":32,"class_classification":33,"jmdn_code":34,"name_similarity":35,"definition_similarity":24,"vector_similarity":36,"score":37},1301,"膀胱用超音波画像診断装置","Ⅱ","70013000",0.271429,0.699467,0.031545,{"medical_device_id":39,"generic_name":40,"class_classification":33,"jmdn_code":41,"name_similarity":42,"definition_similarity":24,"vector_similarity":43,"score":44},1808,"健康検診システム","70178000",0.197183,0.689144,0.0289495,{"medical_device_id":46,"generic_name":47,"class_classification":33,"jmdn_code":48,"name_similarity":49,"definition_similarity":24,"vector_similarity":50,"score":51},2997,"自己検査用尿化学分析器","70186000",0.194444,0.688535,0.0285312,{"medical_device_id":53,"generic_name":54,"class_classification":33,"jmdn_code":55,"name_similarity":56,"definition_similarity":24,"vector_similarity":57,"score":58},1447,"虚血モニタリングシステムモジュール","37249000",0.296875,0.649794,0.0280681,{"medical_device_id":60,"generic_name":61,"class_classification":62,"jmdn_code":63,"name_similarity":64,"definition_similarity":24,"vector_similarity":65,"score":66},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",0.191011,0.671832,0.0271205,{"medical_device_id":68,"generic_name":69,"class_classification":33,"jmdn_code":70,"name_similarity":71,"definition_similarity":24,"vector_similarity":72,"score":73},2998,"自己検査用尿糖計","70188000",0.186667,0.654872,0.0245482,{"medical_device_id":75,"generic_name":76,"class_classification":33,"jmdn_code":77,"name_similarity":78,"definition_similarity":24,"vector_similarity":79,"score":80},1492,"患者モニタシステム","37595000",0.305085,0.631497,0.0163934,{"medical_device_id":82,"generic_name":83,"class_classification":33,"jmdn_code":84,"name_similarity":85,"definition_similarity":24,"vector_similarity":86,"score":87},1528,"分娩監視装置","37796000",0.298507,0.582527,0.016129,{"medical_device_id":89,"generic_name":90,"class_classification":62,"jmdn_code":91,"name_similarity":92,"definition_similarity":24,"vector_similarity":93,"score":94},340,"不整脈モニタリングシステム","43239000",0.294118,0.604534,0.015625,{"medical_device_id":96,"generic_name":97,"class_classification":98,"jmdn_code":99,"name_similarity":100,"definition_similarity":24,"vector_similarity":101,"score":94},3572,"自動尿スクリーニングシステム","Ⅰ","30648000",0.136986,0.685471,[103,107,111,114,118,122,126,129,133,136,139,142,145,148,151,154,157,160],{"product_code":104,"device_name":105,"device_class":8,"k510_count":106},"NQN","Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity",15,{"product_code":108,"device_name":109,"device_class":8,"k510_count":110},"MXZ","Immunohistochemistry Assay, Antibody, Progesterone Receptor",13,{"product_code":112,"device_name":113,"device_class":8,"k510_count":110},"NOT","Microscope, Automated, Image Analysis, Operator Intervention",{"product_code":115,"device_name":116,"device_class":8,"k510_count":117},"MYA","Immunohistochemistry Antibody Assay, Estrogen Receptor",12,{"product_code":119,"device_name":120,"device_class":8,"k510_count":121},"OEO","Automated Digital Image Manual Interpretation Microscope",6,{"product_code":123,"device_name":124,"device_class":8,"k510_count":125},"NJW","Control Material, Her-2\u002FNeu, Immunohistochemistry",2,{"product_code":127,"device_name":128,"device_class":13,"k510_count":26},"NTR","Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells",{"product_code":130,"device_name":131,"device_class":132,"k510_count":24},"LPI","Kit, Assay, Progesterone Receptor","3",{"product_code":134,"device_name":135,"device_class":132,"k510_count":24},"LPJ","Kit, Assay, Estrogen Receptor",{"product_code":137,"device_name":138,"device_class":13,"k510_count":24},"NJT","Immunohistochemistry Reagents And Kits",{"product_code":140,"device_name":141,"device_class":132,"k510_count":24},"NKF","Immunohistochemistry Antibody Assay, C-Kit",{"product_code":143,"device_name":144,"device_class":132,"k510_count":24},"NQF","Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor",{"product_code":146,"device_name":147,"device_class":132,"k510_count":24},"QKF","Immunocytochemistry Assay, P16\u002FKi-67",{"product_code":149,"device_name":150,"device_class":132,"k510_count":24},"QNH","Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay",{"product_code":152,"device_name":153,"device_class":132,"k510_count":24},"QUL","Immunohistochemistry Assay, Antibody, Folr1",{"product_code":155,"device_name":156,"device_class":132,"k510_count":24},"QZJ","Immunohistochemistry Assay, Antibody, Claudin 18",{"product_code":158,"device_name":159,"device_class":132,"k510_count":24},"SBL","Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4",{"product_code":161,"device_name":162,"device_class":132,"k510_count":24},"SER","Immunohistochemistry Assay, Antibody, Met",{"510k":164,"classification":165,"enforcement":166,"event":167,"pma":168,"warning_letter":169},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]