[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NZH":3},{"classification":4,"mappedDevices":29,"similarCandidates":30,"relatedClassifications":112,"syncDates":113,"translation":120,"marketSummary":127,"recalls":144,"k510s":146,"pmas":159},{"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":23,"updated_at":24,"recall_count":25,"latest_recall_date":26,"k510_count":27,"pma_count":25,"event_count":28},5714,"NZH","Medication Management System, Remote","2","880.6315","HO","General Hospital","1","A remote medication management system provides a means for the patient's prescribed medications to be stored in a delivery unit; For a medical provider to remotely schedule the patient's prescribed medications; To provide notification to the patient when the prescribed medications are due to be taken; To release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command; And to provide to the medical provider a history of the event. The system is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":20,"device_class":8,"implant_flag":21,"product_code":6,"review_panel":10,"gmp_exempt_flag":21,"third_party_flag":21,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":20,"life_sustain_support_flag":21,"medical_specialty_description":11,"summary_malfunction_reporting":22},{"k_number":17},[18,19],"DEN060002","K150174","","N","Ineligible","2026-08-18T05:52:52.949882+00:00","2026-08-24T02:00:48.225237+00:00",0,null,2,14,[],[31,40,49,57,66,74,82,90,97,105],{"medical_device_id":32,"generic_name":33,"class_classification":34,"jmdn_code":35,"name_similarity":36,"definition_similarity":37,"vector_similarity":38,"score":39},841,"遠隔照射式治療用放射性核種システム","Ⅲ","38297000",0.28125,0.22449,0.618511,0.0310245,{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},3097,"核医学装置ワークステーション用プログラム","Ⅱ","40937012",0.238806,0.231746,0.603697,0.0277992,{"medical_device_id":50,"generic_name":51,"class_classification":43,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":56},1492,"患者モニタシステム","37595000",0.22,0.258454,0.631727,0.0276233,{"medical_device_id":58,"generic_name":59,"class_classification":60,"jmdn_code":61,"name_similarity":62,"definition_similarity":63,"vector_similarity":64,"score":65},3878,"手術台システム","Ⅰ","37325000",0.234043,0.240506,0.607177,0.0275875,{"medical_device_id":67,"generic_name":68,"class_classification":34,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":73},840,"遠隔照射式治療用放射性核種システム向け輪郭探知器","36499000",0.225,0.239362,0.609251,0.0262796,{"medical_device_id":75,"generic_name":76,"class_classification":34,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},1108,"中心静脈留置型経皮的体温調節装置コントロールユニット","44709003",0.222222,0.210031,0.610742,0.0257287,{"medical_device_id":83,"generic_name":84,"class_classification":34,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},471,"可搬型輸液ポンプマネジメントユニット","36179020",0.224138,0.260479,0.592111,0.0248457,{"medical_device_id":91,"generic_name":92,"class_classification":43,"jmdn_code":93,"name_similarity":78,"definition_similarity":94,"vector_similarity":95,"score":96},3123,"尿動態測定システム用プログラム","14307012",0.234528,0.598425,0.0241841,{"medical_device_id":98,"generic_name":99,"class_classification":43,"jmdn_code":100,"name_similarity":101,"definition_similarity":102,"vector_similarity":103,"score":104},1287,"核医学装置ワークステーション","40937000",0.290909,0.25,0.567592,0.0163934,{"medical_device_id":106,"generic_name":107,"class_classification":43,"jmdn_code":108,"name_similarity":109,"definition_similarity":110,"vector_similarity":111,"score":104},1552,"テレメトリー式生体信号測定装置","32547000",0.145161,0.22063,0.633307,[],{"510k":114,"classification":115,"enforcement":116,"event":117,"pma":118,"warning_letter":119},"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":121,"definition_ja":122,"commentary_ja":123,"model_name":124,"source_hash":125,"reviewed_by":26,"reviewed_at":26,"created_at":126,"updated_at":126},"遠隔服薬管理システム","遠隔服薬管理システムは、患者に処方された薬剤を送達ユニットに保管する手段を提供し、医療提供者が患者に処方された薬剤の服用スケジュールを遠隔で設定できるようにし、処方薬の服用時刻が近づいた際に患者に通知を行い、患者の指示に応じて送達ユニットの患者がアクセス可能なトレイに処方薬を放出し、医療提供者にイベントの履歴を提供するものである。本システムは、在宅またはクリニックにおける患者の治療計画を管理する上で医療提供者を支援する補助として使用することを目的としている。","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)）による審査を経て市販されます。クラスIIは中程度のリスクを有する医療機器区分であり、既存の同等品（プレディケイトデバイス）との実質的同等性を示すことで市販が認められる510(k)の対象となっています。","claude-sonnet-5","a03de511495e5807aa44e5bd559c153e5ba4cc3c1270e5f2c18222bfb0828297","2026-08-24T02:20:14.132666+00:00",{"product_code":6,"summary_ja":128,"stats":129,"stats_hash":142,"model_name":124,"created_at":143,"updated_at":143},"本製品コードにおける510(k)の累計件数は2件で、参入企業数は1社、直近5年間の新規届出は確認されていません。不具合報告（MDR）は累計約10件で、死亡・傷害の報告はなく、不具合（Malfunction）が6件、その他が8件となっており、直近5年間の報告は1件、最新の報告は2024年3月です。回収については累計件数0件で、クラスI・II・IIIいずれも確認されていません。",{"pma":130,"k510":131,"as_of":134,"events":135,"recalls":139,"top_problems":141},{"latest":26,"originals":25,"supplements":25},{"total":27,"last5y":25,"latest":132,"applicants":133},"2015-02-26",1,"2026-08",{"death":25,"other":136,"total":28,"injury":25,"last5y":133,"malfunction":137,"latest_month":138},8,6,"2024-03",{"total":25,"last5y":25,"latest":26,"class_i":25,"class_ii":25,"class_iii":25,"top_root_causes":140},[],[],"1b4cecbdc7359f9efe56befc1828044692ee908468549901136e710c4c415b54","2026-08-24T05:01:48.414996+00:00",{"items":145,"total":25},[],{"items":147,"total":27},[148,154],{"k_number":19,"device_name":149,"applicant":150,"decision_date":132,"clearance_type":151,"decision_code":152,"statement_or_summary":153},"EMMA","Inrange Systems, Inc.","Special","SESE","Statement",{"k_number":18,"device_name":155,"applicant":150,"decision_date":156,"clearance_type":157,"decision_code":158,"statement_or_summary":26},"INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM","2007-06-13","Post-NSE","DENG",{"items":160,"total":25},[]]