[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-MOA":3},{"classification":4,"mappedDevices":25,"similarCandidates":26,"relatedClassifications":96,"syncDates":97,"translation":104,"marketSummary":110,"recalls":125,"k510s":127,"pmas":129},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":9,"implant_flag":13,"life_sustain_support_flag":13,"gmp_exempt_flag":13,"raw":14,"created_at":20,"updated_at":21,"recall_count":22,"latest_recall_date":23,"k510_count":22,"pma_count":24,"event_count":22},1179,"MOA","Analyzer, Diagnostic, Fiber Optic (Colon)","3","","Unknown","GU","2",false,{"openfda":15,"definition":9,"device_name":7,"review_code":9,"device_class":8,"implant_flag":18,"product_code":6,"review_panel":11,"gmp_exempt_flag":18,"third_party_flag":18,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":18,"medical_specialty_description":10,"summary_malfunction_reporting":19},{"pma_number":16},[17],"P990050","N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:48.882786+00:00",0,null,8,[],[27,35,43,50,57,63,70,76,83,89],{"medical_device_id":28,"generic_name":29,"class_classification":30,"jmdn_code":31,"name_similarity":32,"definition_similarity":22,"vector_similarity":33,"score":34},3516,"グルコース分析装置","Ⅰ","36730000",0.209302,0.689851,0.0265409,{"medical_device_id":36,"generic_name":37,"class_classification":38,"jmdn_code":39,"name_similarity":40,"definition_similarity":22,"vector_similarity":41,"score":42},3189,"循環動態解析装置","Ⅱ","71075002",0.215385,0.682861,0.0256452,{"medical_device_id":44,"generic_name":45,"class_classification":30,"jmdn_code":46,"name_similarity":47,"definition_similarity":22,"vector_similarity":48,"score":49},3578,"コロニー定量分析装置","15126000",0.207547,0.685003,0.0252782,{"medical_device_id":51,"generic_name":52,"class_classification":38,"jmdn_code":53,"name_similarity":54,"definition_similarity":22,"vector_similarity":55,"score":56},1649,"軟性大腸鏡","34966000",0.142857,0.751841,0.0163934,{"medical_device_id":58,"generic_name":59,"class_classification":30,"jmdn_code":60,"name_similarity":61,"definition_similarity":22,"vector_similarity":62,"score":56},3835,"診断用ネブライザ","37072000",0.302326,0.513707,{"medical_device_id":64,"generic_name":65,"class_classification":38,"jmdn_code":66,"name_similarity":67,"definition_similarity":22,"vector_similarity":68,"score":69},1769,"超音波軟性大腸鏡","38807000",0.135593,0.748207,0.016129,{"medical_device_id":71,"generic_name":72,"class_classification":30,"jmdn_code":73,"name_similarity":74,"definition_similarity":22,"vector_similarity":75,"score":69},3275,"画像診断用イメージャ","70036000",0.292683,0.626136,{"medical_device_id":77,"generic_name":78,"class_classification":38,"jmdn_code":79,"name_similarity":80,"definition_similarity":22,"vector_similarity":81,"score":82},1687,"ビデオ軟性大腸鏡","36117000",0.127273,0.738666,0.015873,{"medical_device_id":84,"generic_name":85,"class_classification":30,"jmdn_code":86,"name_similarity":87,"definition_similarity":22,"vector_similarity":88,"score":82},3297,"画像診断用シネフィルム","40982000",0.28,0.516952,{"medical_device_id":90,"generic_name":91,"class_classification":38,"jmdn_code":92,"name_similarity":93,"definition_similarity":22,"vector_similarity":94,"score":95},1648,"軟性S字結腸鏡","15057000",0.0175439,0.725313,0.015625,[],{"510k":98,"classification":99,"enforcement":100,"event":101,"pma":102,"warning_letter":103},"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":105,"definition_ja":23,"commentary_ja":106,"model_name":107,"source_hash":108,"reviewed_by":23,"reviewed_at":23,"created_at":109,"updated_at":109},"光ファイバー式大腸診断分析装置","本機器は米国FDAの規制上クラスIIIに分類されており、市販前承認（PMA）の対象となっています。クラスIIIは人体へのリスクが最も高い区分とされる機器に適用され、有効性と安全性を科学的データに基づき審査するPMAの手続きを経なければ市販が認められません。","claude-sonnet-5","ffdc944e4b4d17e1a7257a85b4a60c996a0de081fe2ab04a8817720a21c633da","2026-08-24T02:14:44.518901+00:00",{"product_code":6,"summary_ja":111,"stats":112,"stats_hash":123,"model_name":107,"created_at":124,"updated_at":124},"本製品コードはPMA区分で、本承認1件と一部変更承認7件が確認されており、最新の判定は2009年8月となっています。一方で、不具合報告や回収の累計件数はいずれも0件であり、報告等は確認されていません。",{"pma":113,"k510":117,"as_of":118,"events":119,"recalls":120,"top_problems":122},{"latest":114,"originals":115,"supplements":116},"2009-08-27",1,7,{"total":22,"last5y":22,"latest":23,"applicants":22},"2026-08",{"death":22,"other":22,"total":22,"injury":22,"last5y":22,"malfunction":22,"latest_month":23},{"total":22,"last5y":22,"latest":23,"class_i":22,"class_ii":22,"class_iii":22,"top_root_causes":121},[],[],"293749f0067d2758580a7a9eb951be8c8139386503c263e2c39a5c011631d4fa","2026-08-24T04:54:58.317174+00:00",{"items":126,"total":22},[],{"items":128,"total":22},[],{"items":130,"total":24},[131,135,138,141,144,148,152,156],{"pma_number":17,"supplement_number":132,"trade_name":133,"applicant":134,"decision_date":114},"S007","WAVSTAT OPTICAL BIOPSY SYSTEM","Spectra Science",{"pma_number":17,"supplement_number":136,"trade_name":133,"applicant":134,"decision_date":137},"S006","2006-03-28",{"pma_number":17,"supplement_number":139,"trade_name":133,"applicant":134,"decision_date":140},"S005","2002-08-06",{"pma_number":17,"supplement_number":142,"trade_name":133,"applicant":134,"decision_date":143},"S004","2002-06-14",{"pma_number":17,"supplement_number":145,"trade_name":146,"applicant":134,"decision_date":147},"S003","WAVSTAT (TM) OPTICAL BIOPSY SYSTEM","2001-11-28",{"pma_number":17,"supplement_number":149,"trade_name":150,"applicant":134,"decision_date":151},"S002","WAVSTAT OPTICAL BIOPSY SYTEM","2001-08-17",{"pma_number":17,"supplement_number":153,"trade_name":154,"applicant":134,"decision_date":155},"S001","OPTICAL BIOPSY(TM) SYSTEM","2001-02-16",{"pma_number":17,"supplement_number":9,"trade_name":154,"applicant":134,"decision_date":157},"2000-11-14"]