[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QCC":3},{"classification":4,"mappedDevices":34,"similarCandidates":35,"relatedClassifications":117,"syncDates":121},{"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},2918,"QCC","Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals","2","862.1358","CH","Clinical Chemistry","1","An insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend insulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors.",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":23,"registration_number":25},[18,19,20,21,22],"DEN170043","K191370","K210561","K201476","K232722",[24],"3013922904",[24],"","N","Ineligible","2026-08-18T05:52:50.495594+00:00","2026-08-18T22:05:38.961415+00:00",0,null,5,[],[36,45,54,62,70,78,86,94,101,109],{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":42,"vector_similarity":43,"score":44},455,"ポータブルインスリン用輸液ポンプ","Ⅲ","35983000",0.180723,0.239583,0.722773,0.0320184,{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":50,"definition_similarity":51,"vector_similarity":52,"score":53},2173,"インスリンポンプ用輸液セット","Ⅱ","35838000",0.188889,0.147679,0.683243,0.0315136,{"medical_device_id":55,"generic_name":56,"class_classification":48,"jmdn_code":57,"name_similarity":58,"definition_similarity":59,"vector_similarity":60,"score":61},3117,"色素希釈心拍出量計用プログラム","16177012",0.18,0.186667,0.648519,0.0294372,{"medical_device_id":63,"generic_name":64,"class_classification":39,"jmdn_code":65,"name_similarity":66,"definition_similarity":67,"vector_similarity":68,"score":69},767,"補助循環用バルーンポンプ駆動装置","36340000",0.166667,0.211165,0.619198,0.0256536,{"medical_device_id":71,"generic_name":72,"class_classification":39,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":77},816,"非医療従事者向け自動除細動器","35972020",0.241758,0.105691,0.55715,0.0163934,{"medical_device_id":79,"generic_name":80,"class_classification":39,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":85},1164,"ホウ素中性子捕捉療法用治療計画プログラム","71078003",0.196262,0.224242,0.585717,0.016129,{"medical_device_id":87,"generic_name":88,"class_classification":39,"jmdn_code":89,"name_similarity":90,"definition_similarity":91,"vector_similarity":92,"score":93},1163,"ホウ素中性子捕捉療法用中性子照射装置","71077003",0.191489,0.180628,0.550993,0.015873,{"medical_device_id":95,"generic_name":96,"class_classification":48,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":93},2195,"非静注インフュージョンポンプ","70394000",0.102273,0.216561,0.681475,{"medical_device_id":102,"generic_name":103,"class_classification":39,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":108},448,"汎用輸液ポンプ","13215000",0.113636,0.187151,0.66794,0.015625,{"medical_device_id":110,"generic_name":111,"class_classification":48,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":116},3167,"糖尿病診断補助プログラム","71045002",0.0576923,0.23565,0.663292,0.0153846,[118],{"product_code":119,"device_name":120,"device_class":8,"k510_count":33},"QRX","Continuous Glucose Monitor Informed Insulin Dose Calculator",{"510k":122,"classification":123,"enforcement":124,"event":125,"pma":126,"warning_letter":127},"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","2026-08-19T04:07:02.603+00:00"]