[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QVD":3},{"classification":4,"mappedDevices":30,"similarCandidates":31,"relatedClassifications":112,"syncDates":113,"translation":120,"marketSummary":127,"recalls":140,"k510s":142,"pmas":149},{"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":25,"updated_at":26,"recall_count":27,"latest_recall_date":28,"k510_count":29,"pma_count":27,"event_count":27},3925,"QVD","Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan","2","892.2055","RA","Radiology","1","A radiological machine learning quantitative imaging software with predetermined change control plan is a software-only device which employs machine learning algorithms on radiological images to provide quantitative imaging outputs. The device includes  functions to support outputs such as view selection, segmentation and landmarking. The design specifications include planned modifications that may be made to the device consistent with an established predetermined change control plan.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":22,"device_class":8,"implant_flag":23,"product_code":6,"review_panel":10,"gmp_exempt_flag":23,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":22,"life_sustain_support_flag":23,"medical_specialty_description":11,"summary_malfunction_reporting":24},{"k_number":17,"fei_number":19,"registration_number":21},[18],"DEN220063",[20],"3032008018",[20],"","N","Ineligible","2026-08-18T05:52:51.341121+00:00","2026-08-24T02:00:48.095002+00:00",0,null,1,[],[32,41,49,57,66,74,82,89,97,105],{"medical_device_id":33,"generic_name":34,"class_classification":35,"jmdn_code":36,"name_similarity":37,"definition_similarity":38,"vector_similarity":39,"score":40},1112,"放射線治療用QAQCプログラム","Ⅲ","40887013",0.207547,0.199396,0.738025,0.0315136,{"medical_device_id":42,"generic_name":43,"class_classification":35,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},1111,"放射線治療計画プログラム","40887003",0.212121,0.231638,0.725005,0.03125,{"medical_device_id":50,"generic_name":51,"class_classification":35,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":56},1152,"疾患鑑別用内視鏡画像診断支援プログラム","71066003",0.184615,0.277228,0.716979,0.0298507,{"medical_device_id":58,"generic_name":59,"class_classification":60,"jmdn_code":61,"name_similarity":62,"definition_similarity":63,"vector_similarity":64,"score":65},3034,"コンピューテッドラジオグラフ用プログラム","Ⅱ","70023012",0.161905,0.201807,0.749225,0.0293805,{"medical_device_id":67,"generic_name":68,"class_classification":60,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":73},3144,"神経疾患診断用定量的感覚検査器用プログラム","37349012",0.226562,0.236152,0.699485,0.02886,{"medical_device_id":75,"generic_name":76,"class_classification":60,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},3099,"X線画像診断装置ワークステーション用プログラム","40935012",0.180328,0.218289,0.714913,0.0287904,{"medical_device_id":83,"generic_name":84,"class_classification":60,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":81},3206,"サイズ推定用内視鏡画像診断支援プログラム","71092002",0.186992,0.237143,0.708357,{"medical_device_id":90,"generic_name":91,"class_classification":60,"jmdn_code":92,"name_similarity":93,"definition_similarity":94,"vector_similarity":95,"score":96},3112,"電子管出力読取式デジタルラジオグラフ用プログラム","70025012",0.16129,0.235294,0.721039,0.0285425,{"medical_device_id":98,"generic_name":99,"class_classification":60,"jmdn_code":100,"name_similarity":101,"definition_similarity":102,"vector_similarity":103,"score":104},3101,"汎用画像診断装置ワークステーション用プログラム","70030012",0.181818,0.208571,0.70003,0.0276506,{"medical_device_id":106,"generic_name":107,"class_classification":60,"jmdn_code":108,"name_similarity":101,"definition_similarity":109,"vector_similarity":110,"score":111},3009,"乳房撮影組合せ型X線診断装置用プログラム","70001012",0.197101,0.698644,0.0265191,[],{"510k":114,"classification":115,"enforcement":116,"event":117,"pma":118,"warning_letter":119},"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":121,"definition_ja":122,"commentary_ja":123,"model_name":124,"source_hash":125,"reviewed_by":28,"reviewed_at":28,"created_at":126,"updated_at":126},"変更管理計画付き放射線機械学習定量イメージングソフトウェア","所定の変更管理計画を備えた放射線機械学習定量イメージングソフトウェアとは、放射線画像に機械学習アルゴリズムを適用し、定量的イメージング出力を提供するソフトウェアのみの医療機器である。本機器は、ビュー選択、セグメンテーション及びランドマーキングなどの出力を支援する機能を含む。設計仕様には、確立された所定の変更管理計画に沿って当該機器に加えられる可能性のある計画された変更が含まれる。","本品は米国におけるデバイスクラスがクラスIIに分類されており、市販前届出（510(k)）による審査区分の対象となっています。510(k)では、既に市販されている類似の機器（実質的同等性の比較対象となる機器）との実質的同等性を示すことで市販が認められる仕組みとなっており、クラスIIIで求められる市販前承認（PMA）よりも簡略化された審査プロセスです。","claude-sonnet-5","007939f5bd06c8ebf08c4c6a0ebb1aa96666d64f81bef0f6cf39be191c3fbca6","2026-08-24T03:33:38.802601+00:00",{"product_code":6,"summary_ja":128,"stats":129,"stats_hash":138,"model_name":124,"created_at":139,"updated_at":139},"本製品コードは510(k)累計1件で、直近5年でも1件が届出されており、参入企業数は1社となっています。不具合報告および回収については、いずれも累計0件で、確認されていません。",{"pma":130,"k510":131,"as_of":133,"events":134,"recalls":135,"top_problems":137},{"latest":28,"originals":27,"supplements":27},{"total":29,"last5y":29,"latest":132,"applicants":29},"2023-02-24","2026-08",{"death":27,"other":27,"total":27,"injury":27,"last5y":27,"malfunction":27,"latest_month":28},{"total":27,"last5y":27,"latest":28,"class_i":27,"class_ii":27,"class_iii":27,"top_root_causes":136},[],[],"1076753542a7af83f37b703a6dd10c110bc7b14b8cfb39b9e858527dba88ae24","2026-08-24T05:21:03.140427+00:00",{"items":141,"total":27},[],{"items":143,"total":29},[144],{"k_number":18,"device_name":145,"applicant":146,"decision_date":132,"clearance_type":147,"decision_code":148,"statement_or_summary":28},"Caption Interpretation Automated Ejection Fraction Software","Caption Health, Inc.","Direct","DENG",{"items":150,"total":27},[]]