[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PDY":3},{"classification":4,"mappedDevices":27,"similarCandidates":28,"relatedClassifications":106,"syncDates":107,"translation":114,"marketSummary":121,"recalls":134,"k510s":136,"pmas":143},{"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":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":26,"pma_count":24,"event_count":24},6894,"PDY","Organophosphate Test System","2","862.3652","TX","Clinical Toxicology","1","For the quantitation of specific organophosphate metabolites in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning.  The data obtained by this device is intended to aid in the confirmation and investigation of organophosphate exposure.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":19,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":10,"gmp_exempt_flag":20,"third_party_flag":20,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":19,"life_sustain_support_flag":20,"medical_specialty_description":11,"summary_malfunction_reporting":21},{"k_number":17},[18],"DEN130005","","N","Ineligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:48.095002+00:00",0,null,1,[],[29,38,46,54,62,69,77,83,91,98],{"medical_device_id":30,"generic_name":31,"class_classification":32,"jmdn_code":33,"name_similarity":34,"definition_similarity":35,"vector_similarity":36,"score":37},1808,"健康検診システム","Ⅱ","70178000",0.24,0.157729,0.694277,0.031545,{"medical_device_id":39,"generic_name":40,"class_classification":32,"jmdn_code":41,"name_similarity":42,"definition_similarity":43,"vector_similarity":44,"score":45},1624,"定量的感覚検査用温度分析装置","37350000",0.1875,0.231343,0.672707,0.0280392,{"medical_device_id":47,"generic_name":48,"class_classification":32,"jmdn_code":49,"name_similarity":50,"definition_similarity":51,"vector_similarity":52,"score":53},1571,"基礎代謝測定装置","70081000",0.132075,0.142259,0.710114,0.0163934,{"medical_device_id":55,"generic_name":56,"class_classification":57,"jmdn_code":58,"name_similarity":24,"definition_similarity":59,"vector_similarity":60,"score":61},3570,"尿化学分析装置","Ⅰ","35918000",0.207143,0.709949,0.016129,{"medical_device_id":63,"generic_name":64,"class_classification":57,"jmdn_code":65,"name_similarity":66,"definition_similarity":67,"vector_similarity":68,"score":61},3878,"手術台システム","37325000",0.214286,0.176656,0.485439,{"medical_device_id":70,"generic_name":71,"class_classification":32,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":76},2738,"歯科用けいりん酸セメント","16708000",0.212766,0.184573,0.551192,0.015873,{"medical_device_id":78,"generic_name":79,"class_classification":57,"jmdn_code":80,"name_similarity":24,"definition_similarity":81,"vector_similarity":82,"score":76},3555,"ラジオイムノアッセイ用装置","35506000",0.224806,0.697461,{"medical_device_id":84,"generic_name":85,"class_classification":57,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},3572,"自動尿スクリーニングシステム","30648000",0.153846,0.155039,0.69732,0.015625,{"medical_device_id":92,"generic_name":93,"class_classification":57,"jmdn_code":94,"name_similarity":95,"definition_similarity":96,"vector_similarity":97,"score":90},4310,"シェーバシステム","36436000",0.205882,0.221289,0.554244,{"medical_device_id":99,"generic_name":100,"class_classification":57,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},3259,"X線用テレビ装置","70027000",0.209302,0.182073,0.546886,0.0153846,[],{"510k":108,"classification":109,"enforcement":110,"event":111,"pma":112,"warning_letter":113},"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":115,"definition_ja":116,"commentary_ja":117,"model_name":118,"source_hash":119,"reviewed_by":25,"reviewed_at":25,"created_at":120,"updated_at":120},"有機リン検査システム","コリンエステラーゼ中毒に一致する徴候及び症状を有する個人のヒト尿中の特定の有機リン代謝物の定量のためのものである。本機器によって得られたデータは、有機リン曝露の確認及び調査を補助することを目的とする。","この機器は米国においてクラスIIに分類され、市販前届出（510(k)）の対象となっています。510(k)は、既存の同等な医療機器（プレディケートデバイス）との実質的同等性を示すことで市販が認められる審査区分であり、クラスIIIの機器に適用される市販前承認（PMA）と比較して、相対的にリスクが低い機器に用いられる制度です。","claude-sonnet-5","f6ef1abf220ff57ae356a308ba5f687acbdc395eebf62b48b597f5daa6c7dfd0","2026-08-24T02:30:13.381035+00:00",{"product_code":6,"summary_ja":122,"stats":123,"stats_hash":132,"model_name":118,"created_at":133,"updated_at":133},"Organophosphate Test System（product code: PDY）は、510(k)の累計件数が1件、参入企業数は1社となっており、直近5年間の届出は確認されていません。不具合報告（MDR）については累計報告件数が0件で、報告は確認されていません。回収についても累計件数は0件であり、該当する事例は確認されていません。",{"pma":124,"k510":125,"as_of":127,"events":128,"recalls":129,"top_problems":131},{"latest":25,"originals":24,"supplements":24},{"total":26,"last5y":24,"latest":126,"applicants":26},"2013-08-08","2026-08",{"death":24,"other":24,"total":24,"injury":24,"last5y":24,"malfunction":24,"latest_month":25},{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":130},[],[],"12139050dcd4df3a2bd427621bd1934a841fb2ac17d3a3a4718c01d9dada4852","2026-08-24T05:09:58.149854+00:00",{"items":135,"total":24},[],{"items":137,"total":26},[138],{"k_number":18,"device_name":139,"applicant":140,"decision_date":126,"clearance_type":141,"decision_code":142,"statement_or_summary":25},"QUANTITATION OF ORGANOPHOSPHATE  METABOLITES IN URINE BY LC\u002FMS\u002FMS","Centers for Disease Control and Prevention","Post-NSE","DENG",{"items":144,"total":24},[]]