[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OLY":3},{"classification":4,"mappedDevices":43,"similarCandidates":44,"relatedClassifications":126,"syncDates":173},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":37,"updated_at":38,"recall_count":39,"latest_recall_date":40,"k510_count":41,"pma_count":39,"event_count":42},5721,"OLY","Magnetoencephalograph","2","882.1400","NE","Neurology","1","Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":33,"device_class":8,"implant_flag":34,"product_code":6,"review_panel":10,"gmp_exempt_flag":34,"third_party_flag":35,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":33,"life_sustain_support_flag":34,"medical_specialty_description":11,"summary_malfunction_reporting":36},{"k_number":17,"fei_number":24,"registration_number":29},[18,19,20,21,22,23],"K191785","K854466","K152184","K962317","K962764","K133419",[25,26,27,28],"3004674371","3006563303","3014137562","3002716534",[30,31,27,32],"9680891","9613619","1650946","","N","Y","Eligible","2026-08-18T05:52:52.949882+00:00","2026-08-18T22:05:38.961415+00:00",0,null,6,1,[],[45,53,61,69,77,85,93,102,110,118],{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":42,"definition_similarity":50,"vector_similarity":51,"score":52},1382,"脳磁計","Ⅱ","70048000",0.163265,0.809503,0.0327869,{"medical_device_id":54,"generic_name":55,"class_classification":48,"jmdn_code":56,"name_similarity":57,"definition_similarity":58,"vector_similarity":59,"score":60},3115,"脳磁計用プログラム","70048012",0.628571,0.173432,0.769436,0.0322581,{"medical_device_id":62,"generic_name":63,"class_classification":48,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":68},1454,"脳波計","11467010",0.466667,0.22865,0.763213,0.031498,{"medical_device_id":70,"generic_name":71,"class_classification":48,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":76},1383,"筋磁計","70049000",0.461538,0.160535,0.749894,0.0307692,{"medical_device_id":78,"generic_name":79,"class_classification":48,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},1503,"脳波モニタ","35196000",0.35,0.26009,0.75556,0.0299107,{"medical_device_id":86,"generic_name":87,"class_classification":48,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},1542,"テレメトリー式脳波計","35626000",0.358974,0.210884,0.746148,0.0296443,{"medical_device_id":94,"generic_name":95,"class_classification":96,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":101},3352,"頭皮脳波用電極","Ⅰ","11440001",0.424242,0.164751,0.7202,0.0294372,{"medical_device_id":103,"generic_name":104,"class_classification":48,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":109},1381,"心磁計","70047000",0.413793,0.154882,0.721142,0.0294181,{"medical_device_id":111,"generic_name":112,"class_classification":48,"jmdn_code":113,"name_similarity":114,"definition_similarity":115,"vector_similarity":116,"score":117},1297,"超音波頭部用画像診断装置","11387000",0.518519,0.216216,0.687827,0.028373,{"medical_device_id":119,"generic_name":120,"class_classification":48,"jmdn_code":121,"name_similarity":122,"definition_similarity":123,"vector_similarity":124,"score":125},1538,"胎児脳波モニタ","32660000",0.304348,0.200873,0.722171,0.0282194,[127,131,135,139,143,147,151,155,159,163,167,170],{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"GWQ","Full-Montage Standard Electroencephalograph",189,{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"OLV","Standard Polysomnograph With Electroencephalograph",64,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"OLT","Non-Normalizing Quantitative Electroencephalograph Software",55,{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"OMB","Automatic Event Detection Software For Full-Montage Electroencephalograph",42,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"OLW","Index-Generating Electroencephalograph Software",39,{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"OLZ","Automatic Event Detection Software For Polysomnograph With Electroencephalograph",37,{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"OMC","Reduced- Montage Standard Electroencephalograph",29,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"OLX","Source Localization Software For Electroencephalograph Or Magnetoencephalograph",24,{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"OMA","Amplitude-Integrated Electroencephalograph",16,{"product_code":164,"device_name":165,"device_class":8,"k510_count":166},"OLU","Normalizing Quantitative Electroencephalograph Software",13,{"product_code":168,"device_name":169,"device_class":8,"k510_count":42},"ORT","Burst Suppression Detection Software For Electroencephalograph",{"product_code":171,"device_name":172,"device_class":8,"k510_count":42},"SFK","Respiratory Effort Belt For Polysomnography",{"510k":174,"classification":175,"enforcement":176,"event":177,"pma":178,"warning_letter":179},"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"]