[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PIW":3},{"classification":4,"mappedDevices":40,"similarCandidates":41,"relatedClassifications":124,"syncDates":125,"translation":132,"marketSummary":139,"recalls":153,"k510s":155,"pmas":191},{"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":35,"updated_at":36,"recall_count":37,"latest_recall_date":38,"k510_count":39,"pma_count":37,"event_count":37},6689,"PIW","Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid","2","882.1450","NE","Neurology","1","A prescription device that uses a patient¿s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient¿s brain in the setting of trauma.  The Brain Injury Adjunctive Interpretive EEG Assessment Aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":32,"device_class":8,"implant_flag":33,"product_code":6,"review_panel":10,"gmp_exempt_flag":33,"third_party_flag":33,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":32,"life_sustain_support_flag":33,"medical_specialty_description":11,"summary_malfunction_reporting":34},{"k_number":17,"fei_number":27,"registration_number":31},[18,19,20,21,22,23,24,25,26],"K181785","K181179","K143643","K190815","K243426","K161068","K231914","K183241","DEN140025",[28,29,30],"3008660657","3018238599","1287329",[28,29,30],"","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:49.169481+00:00",0,null,9,[],[42,51,59,67,75,84,92,100,108,116],{"medical_device_id":43,"generic_name":44,"class_classification":45,"jmdn_code":46,"name_similarity":47,"definition_similarity":48,"vector_similarity":49,"score":50},1454,"脳波計","Ⅱ","11467010",0.328358,0.27,0.730811,0.0325225,{"medical_device_id":52,"generic_name":53,"class_classification":45,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},1464,"脳波用増幅器","36740000",0.302632,0.213483,0.717024,0.03125,{"medical_device_id":60,"generic_name":61,"class_classification":45,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},1503,"脳波モニタ","35196000",0.269231,0.261029,0.732321,0.0308862,{"medical_device_id":68,"generic_name":69,"class_classification":45,"jmdn_code":70,"name_similarity":71,"definition_similarity":72,"vector_similarity":73,"score":74},1519,"脳波モジュール","37323000",0.272727,0.284123,0.726081,0.0307984,{"medical_device_id":76,"generic_name":77,"class_classification":78,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},3352,"頭皮脳波用電極","Ⅰ","11440001",0.314286,0.244898,0.682931,0.0298277,{"medical_device_id":85,"generic_name":86,"class_classification":45,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},1542,"テレメトリー式脳波計","35626000",0.306667,0.251497,0.688884,0.0297619,{"medical_device_id":93,"generic_name":94,"class_classification":45,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},1458,"脳波スペクトル分析装置","35777000",0.258824,0.198529,0.712281,0.0288981,{"medical_device_id":101,"generic_name":102,"class_classification":45,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},1547,"テレメトリー式脳波受信機","36381000",0.289157,0.189091,0.67671,0.0283716,{"medical_device_id":109,"generic_name":110,"class_classification":45,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},3133,"脳波モニタ用プログラム","35196012",0.233333,0.299003,0.705462,0.0278638,{"medical_device_id":117,"generic_name":118,"class_classification":45,"jmdn_code":119,"name_similarity":120,"definition_similarity":121,"vector_similarity":122,"score":123},1538,"胎児脳波モニタ","32660000",0.25,0.248148,0.695143,0.0278261,[],{"510k":126,"classification":127,"enforcement":128,"event":129,"pma":130,"warning_letter":131},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":133,"definition_ja":134,"commentary_ja":135,"model_name":136,"source_hash":137,"reviewed_by":38,"reviewed_at":38,"created_at":138,"updated_at":138},"脳損傷補助解釈用脳波評価支援装置","処方箋機器であり、患者の脳波（EEG）を用いて、外傷の状況における患者の脳の構造的状態の解釈を提供するものである。脳損傷補助解釈用脳波評価支援装置は、標準的な臨床診療の補助としてのみ使用されるものであり、他に有効な診断方法が存在する医学的状態に対する評価補助としてのみ用いられる。","本品は米国においてクラスIIに分類されており、市販前届出（510(k)）の対象となる医療機器です。510(k)では、既存の同等の機器（既承認機器）との実質的同等性を示すことにより市販が認められ、クラスIII機器に求められる市販前承認（PMA）のような厳格な臨床データの提出は原則として要求されません。","claude-sonnet-5","b427b3cd8f53e7fcd48c0560e266eb5ced23a89abcb068a46ffb05658b8f0b07","2026-08-24T02:30:13.381035+00:00",{"product_code":6,"summary_ja":140,"stats":141,"stats_hash":151,"model_name":136,"created_at":152,"updated_at":152},"510(k)の累計件数は9件で、参入企業数は2社、直近5年では約2件の届出が確認されており、最新の判定は2025年3月です。PMAの承認実績は確認されていません。不具合報告および回収については、いずれも累計件数が0件であり、報告は確認されていません。",{"pma":142,"k510":143,"as_of":146,"events":147,"recalls":148,"top_problems":150},{"latest":38,"originals":37,"supplements":37},{"total":39,"last5y":144,"latest":145,"applicants":144},2,"2025-03-27","2026-08",{"death":37,"other":37,"total":37,"injury":37,"last5y":37,"malfunction":37,"latest_month":38},{"total":37,"last5y":37,"latest":38,"class_i":37,"class_ii":37,"class_iii":37,"top_root_causes":149},[],[],"d286c96d68c18b34beceebc71decccff693ece98e720c5f4c9c8444ec5c127e6","2026-08-24T05:09:58.149854+00:00",{"items":154,"total":37},[],{"items":156,"total":39},[157,163,166,170,173,176,180,183,186],{"k_number":22,"device_name":158,"applicant":159,"decision_date":145,"clearance_type":160,"decision_code":161,"statement_or_summary":162},"Nurochek-Pro System","Headsafe Mfg Pty, Ltd.","Traditional","SESE","Summary",{"k_number":24,"device_name":164,"applicant":159,"decision_date":165,"clearance_type":160,"decision_code":161,"statement_or_summary":162},"Nurochek-II System","2023-12-27",{"k_number":21,"device_name":167,"applicant":168,"decision_date":169,"clearance_type":160,"decision_code":161,"statement_or_summary":162},"BrainScope TBI","Brainscope Company, Inc.","2019-09-11",{"k_number":25,"device_name":171,"applicant":168,"decision_date":172,"clearance_type":160,"decision_code":161,"statement_or_summary":162},"BrainScope TBI (Model: Ahead 400)","2019-02-19",{"k_number":18,"device_name":174,"applicant":168,"decision_date":175,"clearance_type":160,"decision_code":161,"statement_or_summary":162},"Modified BrainScope One","2018-12-19",{"k_number":19,"device_name":177,"applicant":168,"decision_date":178,"clearance_type":179,"decision_code":161,"statement_or_summary":162},"BrainScope One","2018-05-18","Special",{"k_number":23,"device_name":181,"applicant":168,"decision_date":182,"clearance_type":160,"decision_code":161,"statement_or_summary":162},"Ahead 300","2016-09-22",{"k_number":20,"device_name":184,"applicant":168,"decision_date":185,"clearance_type":160,"decision_code":161,"statement_or_summary":162},"Brainscope Ahead 200","2015-05-15",{"k_number":26,"device_name":187,"applicant":168,"decision_date":188,"clearance_type":189,"decision_code":190,"statement_or_summary":38},"BrainScope Ahead 100","2014-11-17","Direct","DENG",{"items":192,"total":37},[]]