[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PJA":3},{"classification":4,"mappedDevices":40,"similarCandidates":41,"relatedClassifications":122,"syncDates":127,"recalls":134,"k510s":136,"pmas":170},{"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":34,"updated_at":35,"recall_count":36,"latest_recall_date":37,"k510_count":38,"pma_count":36,"event_count":39},5074,"PJA","Coronary Vascular Physiologic Simulation Software","2","870.1415","CV","Cardiovascular","1","A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":31,"device_class":8,"implant_flag":32,"product_code":6,"review_panel":10,"gmp_exempt_flag":32,"third_party_flag":32,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":31,"life_sustain_support_flag":32,"medical_specialty_description":11,"summary_malfunction_reporting":33},{"k_number":17,"fei_number":27,"registration_number":30},[18,19,20,21,22,23,24,25,26],"K213857","DEN130045","K152733","K250902","K190925","K182035","K213657","K203329","K161772",[28,29],"3025430791","3021637148",[28,29],"","N","Ineligible","2026-08-18T05:52:52.566809+00:00","2026-08-18T22:05:38.961415+00:00",0,null,9,137,[],[42,51,59,67,75,83,91,99,107,114],{"medical_device_id":43,"generic_name":44,"class_classification":45,"jmdn_code":46,"name_similarity":47,"definition_similarity":48,"vector_similarity":49,"score":50},3139,"テレメトリー式生体信号測定装置用プログラム","Ⅱ","32547012",0.297297,0.218341,0.699108,0.0293805,{"medical_device_id":52,"generic_name":53,"class_classification":45,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},3082,"X線CT組合せ型循環器X線診断装置用プログラム","70003012",0.211111,0.222222,0.701094,0.0280833,{"medical_device_id":60,"generic_name":61,"class_classification":45,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},3012,"循環器用X線透視診断装置用プログラム","37612012",0.186275,0.186131,0.75717,0.0272401,{"medical_device_id":68,"generic_name":69,"class_classification":45,"jmdn_code":70,"name_similarity":71,"definition_similarity":72,"vector_similarity":73,"score":74},3169,"ICG検査用画像解析プログラム","71047002",0.220779,0.146875,0.692457,0.0266879,{"medical_device_id":76,"generic_name":77,"class_classification":45,"jmdn_code":78,"name_similarity":79,"definition_similarity":80,"vector_similarity":81,"score":82},3117,"色素希釈心拍出量計用プログラム","16177012",0.2,0.184549,0.69206,0.0243939,{"medical_device_id":84,"generic_name":85,"class_classification":45,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},3152,"ベクトル心電計用プログラム","14345012",0.161765,0.212389,0.758154,0.0163934,{"medical_device_id":92,"generic_name":93,"class_classification":45,"jmdn_code":94,"name_similarity":95,"definition_similarity":96,"vector_similarity":97,"score":98},3145,"前庭機能熱刺激装置用プログラム","34891012",0.283784,0.237885,0.638363,0.016129,{"medical_device_id":100,"generic_name":101,"class_classification":45,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":106},1476,"生体信号調整装置","32520000",0.269841,0.221649,0.591615,0.015873,{"medical_device_id":108,"generic_name":109,"class_classification":45,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":106},3177,"循環動態解析プログラム","61213002",0.146067,0.189189,0.755956,{"medical_device_id":115,"generic_name":116,"class_classification":45,"jmdn_code":117,"name_similarity":118,"definition_similarity":119,"vector_similarity":120,"score":121},1630,"生理学的神経筋機能分析装置","17929000",0.277778,0.149215,0.604584,0.015625,[123],{"product_code":124,"device_name":125,"device_class":8,"k510_count":126},"QEK","Angiographic Coronary Vascular Physiologic Simulation Software",2,{"510k":128,"classification":129,"enforcement":130,"event":131,"pma":132,"warning_letter":133},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00",{"items":135,"total":36},[],{"items":137,"total":38},[138,145,147,151,153,156,160,162,164],{"k_number":21,"device_name":139,"applicant":140,"decision_date":141,"clearance_type":142,"decision_code":143,"statement_or_summary":144},"HeartFlow Analysis","HeartFlow, Inc.","2025-07-18","Traditional","SESE","Summary",{"k_number":18,"device_name":139,"applicant":140,"decision_date":146,"clearance_type":142,"decision_code":143,"statement_or_summary":144},"2022-10-14",{"k_number":24,"device_name":148,"applicant":149,"decision_date":150,"clearance_type":142,"decision_code":143,"statement_or_summary":144},"DEEPVESSEL FFR","Keyamed Na, Inc.","2022-04-01",{"k_number":25,"device_name":139,"applicant":140,"decision_date":152,"clearance_type":142,"decision_code":143,"statement_or_summary":144},"2021-01-08",{"k_number":22,"device_name":154,"applicant":140,"decision_date":155,"clearance_type":142,"decision_code":143,"statement_or_summary":144},"HeartFlow FFRct Analysis","2019-08-15",{"k_number":23,"device_name":157,"applicant":140,"decision_date":158,"clearance_type":159,"decision_code":143,"statement_or_summary":144},"FFRct","2018-12-06","Special",{"k_number":26,"device_name":157,"applicant":140,"decision_date":161,"clearance_type":142,"decision_code":143,"statement_or_summary":144},"2016-08-24",{"k_number":20,"device_name":157,"applicant":140,"decision_date":163,"clearance_type":142,"decision_code":143,"statement_or_summary":144},"2016-01-13",{"k_number":19,"device_name":165,"applicant":166,"decision_date":167,"clearance_type":168,"decision_code":169,"statement_or_summary":37},"HEARTFLOW FFRCT","Heartflow","2014-11-26","Direct","DENG",{"items":171,"total":36},[]]