[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QQI":3},{"classification":4,"mappedDevices":34,"similarCandidates":35,"relatedClassifications":119,"syncDates":120,"translation":127,"marketSummary":134,"recalls":148,"k510s":150,"pmas":169},{"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":29,"updated_at":30,"recall_count":31,"latest_recall_date":32,"k510_count":33,"pma_count":31,"event_count":31},1600,"QQI","Interventional Cardiovascular Implant Simulation Software Device","2","870.1405","CV","Cardiovascular","1","An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":26,"device_class":8,"implant_flag":27,"product_code":6,"review_panel":10,"gmp_exempt_flag":27,"third_party_flag":27,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":26,"life_sustain_support_flag":27,"medical_specialty_description":11,"summary_malfunction_reporting":28},{"k_number":17,"fei_number":22,"registration_number":25},[18,19,20,21],"DEN200030","K250635","K214066","K223809",[23,24],"3020703662","3030707552",[23,24],"","N","Ineligible","2026-08-18T05:52:49.347546+00:00","2026-08-24T02:00:47.318533+00:00",0,null,4,[],[36,45,54,62,71,79,87,95,104,112],{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":42,"vector_similarity":43,"score":44},3164,"歯科インプラント用治療計画支援プログラム","Ⅱ","71043002",0.247059,0.212454,0.724088,0.0317781,{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":50,"definition_similarity":51,"vector_similarity":52,"score":53},1125,"植込み能動型機器管理用プログラム","Ⅲ","71052003",0.3125,0.259843,0.69853,0.0310993,{"medical_device_id":55,"generic_name":56,"class_classification":39,"jmdn_code":57,"name_similarity":58,"definition_similarity":59,"vector_similarity":60,"score":61},3012,"循環器用X線透視診断装置用プログラム","37612012",0.231481,0.193038,0.704019,0.0296703,{"medical_device_id":63,"generic_name":64,"class_classification":65,"jmdn_code":66,"name_similarity":67,"definition_similarity":68,"vector_similarity":69,"score":70},225,"心血管用ステント","Ⅳ","34179000",0.285714,0.213699,0.680668,0.028629,{"medical_device_id":72,"generic_name":73,"class_classification":39,"jmdn_code":74,"name_similarity":75,"definition_similarity":76,"vector_similarity":77,"score":78},3135,"心臓内オキシメータ用プログラム","15200012",0.202532,0.228464,0.701948,0.0267794,{"medical_device_id":80,"generic_name":81,"class_classification":48,"jmdn_code":82,"name_similarity":83,"definition_similarity":84,"vector_similarity":85,"score":86},689,"非中心循環系塞栓形成インプラントキット","70512000",0.202247,0.229299,0.698181,0.0258564,{"medical_device_id":88,"generic_name":89,"class_classification":39,"jmdn_code":90,"name_similarity":91,"definition_similarity":92,"vector_similarity":93,"score":94},2208,"植込みポート用医薬品注入器具","70401000",0.227848,0.178404,0.674776,0.0245693,{"medical_device_id":96,"generic_name":97,"class_classification":98,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":103},3255,"循環器X線診断装置用電動式患者台","Ⅰ","40660000",0.192308,0.215789,0.722778,0.016129,{"medical_device_id":105,"generic_name":106,"class_classification":48,"jmdn_code":107,"name_similarity":108,"definition_similarity":109,"vector_similarity":110,"score":111},499,"植込み型縫合糸固定用具","70426000",0.28,0.199301,0.596518,0.015873,{"medical_device_id":113,"generic_name":114,"class_classification":39,"jmdn_code":115,"name_similarity":116,"definition_similarity":117,"vector_similarity":118,"score":111},3152,"ベクトル心電計用プログラム","14345012",0.197368,0.220974,0.719854,[],{"510k":121,"classification":122,"enforcement":123,"event":124,"pma":125,"warning_letter":126},"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":128,"definition_ja":129,"commentary_ja":130,"model_name":131,"source_hash":132,"reviewed_by":32,"reviewed_at":32,"created_at":133,"updated_at":133},"循環器インターベンション用インプラントシミュレーションソフトウェア","循環器インターベンション用インプラントシミュレーションソフトウェア機器とは、患者の心血管解剖学的構造内における循環器インターベンション用インプラント機器のコンピュータシミュレーションを提供する処方箋機器である。当該機器は、循環器インターベンション用インプラント機器と患者固有の解剖学的環境との相互作用を予測するための計算モデリングを実行する。","この機器は米国のデバイスクラス分類ではクラスIIに該当し、市販前届出（510(k)）による審査を経て市販が認められる区分に位置づけられています。クラスIIは中程度のリスクを有する医療機器を対象とし、既存の同等品との実質的同等性を示すことで市販が可能となる制度です。","claude-sonnet-5","9fa112a34be45d4b14235be369536de04e4d9ad4a8019e4ab573a82cd32618b8","2026-08-24T03:31:52.244646+00:00",{"product_code":6,"summary_ja":135,"stats":136,"stats_hash":146,"model_name":131,"created_at":147,"updated_at":147},"510(k)の累計件数は4件で、申請企業数は2社、直近5年間も4件の届出があり、最新の判定は2025年11月となっています。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、確認されていません。",{"pma":137,"k510":138,"as_of":141,"events":142,"recalls":143,"top_problems":145},{"latest":32,"originals":31,"supplements":31},{"total":33,"last5y":33,"latest":139,"applicants":140},"2025-11-25",2,"2026-08",{"death":31,"other":31,"total":31,"injury":31,"last5y":31,"malfunction":31,"latest_month":32},{"total":31,"last5y":31,"latest":32,"class_i":31,"class_ii":31,"class_iii":31,"top_root_causes":144},[],[],"53097ae4a47025775a673172811e27b477293d458b418d6cc934e1498fd76069","2026-08-24T05:19:21.416523+00:00",{"items":149,"total":31},[],{"items":151,"total":33},[152,158,162,165],{"k_number":19,"device_name":153,"applicant":154,"decision_date":139,"clearance_type":155,"decision_code":156,"statement_or_summary":157},"FEops HEARTguide Simulation Application","Feops NV","Traditional","SESE","Summary",{"k_number":21,"device_name":159,"applicant":160,"decision_date":161,"clearance_type":155,"decision_code":156,"statement_or_summary":157},"PrecisionTAVI (v1.1)","Dasi Simulations","2023-05-30",{"k_number":20,"device_name":163,"applicant":154,"decision_date":164,"clearance_type":155,"decision_code":156,"statement_or_summary":157},"FEops HEARTguide","2022-02-25",{"k_number":18,"device_name":163,"applicant":154,"decision_date":166,"clearance_type":167,"decision_code":168,"statement_or_summary":32},"2021-09-08","Direct","DENG",{"items":170,"total":31},[]]