[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PDR":3},{"classification":4,"mappedDevices":28,"similarCandidates":29,"relatedClassifications":109,"syncDates":110},{"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":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":21,"updated_at":22,"recall_count":23,"latest_recall_date":24,"k510_count":25,"pma_count":26,"event_count":27},5886,"PDR","Computer-Assisted Personalized Sedation System","3","","Unknown","AN","2","Computer assisted system to administer a drug and control depth of sedation and provide monitoring and alarms for physiological vital signs and other parameters of sedation.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":19,"product_code":6,"review_panel":11,"gmp_exempt_flag":19,"third_party_flag":19,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":19,"medical_specialty_description":10,"summary_malfunction_reporting":20},{"pma_number":17},[18],"P080009","N","Eligible","2026-08-18T05:52:52.949882+00:00","2026-08-18T22:05:38.961415+00:00",1,"2015-09-02",0,12,13,[],[30,39,47,56,64,71,79,86,94,101],{"medical_device_id":31,"generic_name":32,"class_classification":33,"jmdn_code":34,"name_similarity":35,"definition_similarity":36,"vector_similarity":37,"score":38},1295,"超音波装置用コンピュータ","Ⅱ","40845000",0.238806,0.260331,0.678826,0.03125,{"medical_device_id":40,"generic_name":41,"class_classification":33,"jmdn_code":42,"name_similarity":43,"definition_similarity":44,"vector_similarity":45,"score":46},3002,"体温調節装置システム","71036002",0.192982,0.197133,0.672947,0.026289,{"medical_device_id":48,"generic_name":49,"class_classification":50,"jmdn_code":51,"name_similarity":52,"definition_similarity":53,"vector_similarity":54,"score":55},820,"自動腹膜灌流用装置","Ⅲ","11226000",0.208955,0.12987,0.647849,0.0235816,{"medical_device_id":57,"generic_name":58,"class_classification":33,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},1492,"患者モニタシステム","37595000",0.147541,0.236152,0.707324,0.0163934,{"medical_device_id":65,"generic_name":66,"class_classification":33,"jmdn_code":67,"name_similarity":68,"definition_similarity":69,"vector_similarity":70,"score":63},1588,"X線CT診断装置キセノンガス管理システム","40907000",0.282051,0.272031,0.603214,{"medical_device_id":72,"generic_name":73,"class_classification":33,"jmdn_code":74,"name_similarity":75,"definition_similarity":76,"vector_similarity":77,"score":78},1273,"人体回転型全身用X線CT診断装置","37618020",0.272727,0.194611,0.571825,0.016129,{"medical_device_id":80,"generic_name":81,"class_classification":33,"jmdn_code":82,"name_similarity":83,"definition_similarity":84,"vector_similarity":85,"score":78},1809,"バイオフィードバックシステム","10396000",0.125,0.194872,0.68251,{"medical_device_id":87,"generic_name":88,"class_classification":33,"jmdn_code":89,"name_similarity":90,"definition_similarity":91,"vector_similarity":92,"score":93},1275,"アーム型X線CT診断装置","70006000",0.25,0.189274,0.587277,0.015873,{"medical_device_id":95,"generic_name":96,"class_classification":33,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":93},1607,"コンピュータ制御オージオメータ","41187000",0.183333,0.170968,0.680687,{"medical_device_id":102,"generic_name":103,"class_classification":50,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":108},456,"注射筒輸液ポンプコントロールユニット","37217000",0.0972222,0.210714,0.674501,0.0153846,[],{"510k":111,"classification":112,"enforcement":113,"event":114,"pma":115,"warning_letter":116},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-18T22:42:53.076+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]