[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-POK":3},{"classification":4,"mappedDevices":69,"similarCandidates":70,"relatedClassifications":153,"syncDates":154,"translation":161,"marketSummary":168,"recalls":184,"k510s":186,"pmas":262},{"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":63,"updated_at":64,"recall_count":65,"latest_recall_date":66,"k510_count":67,"pma_count":65,"event_count":68},1916,"POK","Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer","2","892.2060","RA","Radiology","1","Assist users in characterizing lesions identified on acquired medical images",false,{"openfda":16,"definition":13,"device_name":7,"review_code":60,"device_class":8,"implant_flag":61,"product_code":6,"review_panel":10,"gmp_exempt_flag":61,"third_party_flag":61,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":60,"life_sustain_support_flag":61,"medical_specialty_description":11,"summary_malfunction_reporting":62},{"k_number":17,"fei_number":41,"registration_number":58},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"K202300","K254161","K201555","K200760","K243294","K252294","K221564","K242130","K241245","K232156","K212616","K234141","K261519","K250221","K190442","K242342","K243614","K251071","K251769","DEN170022","K253884","K221624","K233342",[42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57],"3007301305","3044622018","3032008018","3010119782","3015478020","3014269683","2518586","3033588305","3017604664","3016585383","3017210169","3034527804","3019216","3040335643","3029937167","3022983474",[42,43,59,44,45,46,48,49,50,51,52,53,54,55,56,57],"3011205675","","N","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-24T02:00:49.169481+00:00",0,null,23,1,[],[71,80,88,96,105,113,121,129,137,145],{"medical_device_id":72,"generic_name":73,"class_classification":74,"jmdn_code":75,"name_similarity":76,"definition_similarity":77,"vector_similarity":78,"score":79},3192,"病変検出用内視鏡画像診断支援プログラム","Ⅱ","71080002",0.227723,0.120536,0.769425,0.0277571,{"medical_device_id":81,"generic_name":82,"class_classification":74,"jmdn_code":83,"name_similarity":84,"definition_similarity":85,"vector_similarity":86,"score":87},3009,"乳房撮影組合せ型X線診断装置用プログラム","70001012",0.278846,0.0837209,0.658922,0.027619,{"medical_device_id":89,"generic_name":90,"class_classification":74,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":95},3013,"乳房用X線診断装置用プログラム","37630012",0.284091,0.0750988,0.655294,0.0273641,{"medical_device_id":97,"generic_name":98,"class_classification":99,"jmdn_code":100,"name_similarity":101,"definition_similarity":102,"vector_similarity":103,"score":104},1152,"疾患鑑別用内視鏡画像診断支援プログラム","Ⅲ","71066003",0.224299,0.116279,0.733315,0.0269841,{"medical_device_id":106,"generic_name":107,"class_classification":74,"jmdn_code":108,"name_similarity":109,"definition_similarity":110,"vector_similarity":111,"score":112},3015,"腹部集団検診用X線診断装置用プログラム","37675032",0.242991,0.0748899,0.667276,0.0268384,{"medical_device_id":114,"generic_name":115,"class_classification":74,"jmdn_code":116,"name_similarity":117,"definition_similarity":118,"vector_similarity":119,"score":120},3034,"コンピューテッドラジオグラフ用プログラム","70023012",0.285714,0.0841584,0.645779,0.0260365,{"medical_device_id":122,"generic_name":123,"class_classification":74,"jmdn_code":124,"name_similarity":125,"definition_similarity":126,"vector_similarity":127,"score":128},3026,"X線CT診断装置用プログラム","37619012",0.264368,0.0811966,0.646807,0.0250623,{"medical_device_id":130,"generic_name":131,"class_classification":74,"jmdn_code":132,"name_similarity":133,"definition_similarity":134,"vector_similarity":135,"score":136},3012,"循環器用X線透視診断装置用プログラム","37612012",0.254545,0.07393,0.649396,0.0248918,{"medical_device_id":138,"generic_name":139,"class_classification":74,"jmdn_code":140,"name_similarity":141,"definition_similarity":142,"vector_similarity":143,"score":144},3144,"神経疾患診断用定量的感覚検査器用プログラム","37349012",0.252336,0.0892857,0.647859,0.0248276,{"medical_device_id":146,"generic_name":147,"class_classification":74,"jmdn_code":148,"name_similarity":149,"definition_similarity":150,"vector_similarity":151,"score":152},3016,"胸部集団検診用X線診断装置用プログラム","37627052",0.235849,0.0765766,0.655598,0.0243148,[],{"510k":155,"classification":156,"enforcement":157,"event":158,"pma":159,"warning_letter":160},"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":162,"definition_ja":163,"commentary_ja":164,"model_name":165,"source_hash":166,"reviewed_by":66,"reviewed_at":66,"created_at":167,"updated_at":167},"がん疑い病変用コンピュータ支援診断ソフトウェア","取得した医用画像上で特定された病変の性状評価において使用者を支援するものである。","本品は米国においてクラスIIに分類される医療機器であり、市販前届出（510(k)）による審査を経て市販が認められます。クラスIIは中程度のリスクを有する機器を対象とする区分であり、既存の同等な機器との実質的同等性の確認に基づいて審査が行われます。放射線科領域で用いられるソフトウェアとして、この区分に位置づけられています。","claude-sonnet-5","1ebebaf09f6f0e6a6751ea74ddc5839a5d202ff2fbb2760c934d1cdf689efbe6","2026-08-24T02:33:49.041043+00:00",{"product_code":6,"summary_ja":169,"stats":170,"stats_hash":182,"model_name":165,"created_at":183,"updated_at":183},"510(k)の累計届出件数は約20件で、参入企業数は15社、直近5年間でも約20件の届出が確認されており、2026年7月にも判定が行われるなど市場での動きが見られます。不具合報告は累計1件のみで、Malfunction（不具合）に分類されており、死亡・傷害の報告は確認されていません。回収については累計0件で、クラスI・II・IIIいずれも報告されていません。",{"pma":171,"k510":172,"as_of":176,"events":177,"recalls":179,"top_problems":181},{"latest":66,"originals":65,"supplements":65},{"total":67,"last5y":173,"latest":174,"applicants":175},18,"2026-07-02",15,"2026-08",{"death":65,"other":65,"total":68,"injury":65,"last5y":65,"malfunction":68,"latest_month":178},"2021-01",{"total":65,"last5y":65,"latest":66,"class_i":65,"class_ii":65,"class_iii":65,"top_root_causes":180},[],[],"1511d064a1f866e26427c41213c24a4036680edcaec84693c22e194ff82141fc","2026-08-24T05:13:39.867404+00:00",{"items":185,"total":65},[],{"items":187,"total":67},[188,194,199,203,207,211,215,218,220,224,227,230,234,238,242,246,248,252,254,258],{"k_number":38,"device_name":189,"applicant":190,"decision_date":174,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"Koios DS (3.8)","Koios Medical, Inc.","Traditional","SESE","Summary",{"k_number":30,"device_name":195,"applicant":196,"decision_date":197,"clearance_type":198,"decision_code":192,"statement_or_summary":193},"Sonio Suspect","Sonio","2026-06-04","Special",{"k_number":19,"device_name":200,"applicant":201,"decision_date":202,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"Automated Aortic Stenosis Software (AutoAS)","GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC","2026-03-27",{"k_number":36,"device_name":204,"applicant":205,"decision_date":206,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"RevealAI-Lung","Precision Medical Ventures, Inc. Dba Revealdx","2026-01-30",{"k_number":23,"device_name":208,"applicant":209,"decision_date":210,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"Fetal EchoScan (v1.2)","Brightheart","2025-12-08",{"k_number":31,"device_name":212,"applicant":213,"decision_date":214,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"StrokeSENS ASPECTS Software Application","Circle Cardiovascular Imaging, Inc.","2025-07-01",{"k_number":35,"device_name":216,"applicant":209,"decision_date":217,"clearance_type":198,"decision_code":192,"statement_or_summary":193},"Fetal EchoScan (v1.1)","2025-05-02",{"k_number":34,"device_name":195,"applicant":196,"decision_date":219,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"2025-02-21",{"k_number":22,"device_name":221,"applicant":222,"decision_date":223,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"Brainomix 360 e-ASPECTS","Brainomix Limited","2025-02-14",{"k_number":25,"device_name":225,"applicant":190,"decision_date":226,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"Koios DS","2024-11-15",{"k_number":33,"device_name":228,"applicant":209,"decision_date":229,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"Fetal EchoScan","2024-11-14",{"k_number":26,"device_name":231,"applicant":232,"decision_date":233,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"EchoSolv AS","Echo IQ, Ltd.","2024-10-04",{"k_number":29,"device_name":235,"applicant":236,"decision_date":237,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"AISAP Cardio V1.0","Aisap","2024-08-01",{"k_number":40,"device_name":239,"applicant":240,"decision_date":241,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"CINA-ASPECTS","Avicenna.Ai","2024-03-15",{"k_number":27,"device_name":243,"applicant":244,"decision_date":245,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"Rapid ASPECTS (v3)","Ischemaview, Inc.","2024-01-19",{"k_number":24,"device_name":221,"applicant":222,"decision_date":247,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"2023-02-23",{"k_number":39,"device_name":249,"applicant":250,"decision_date":251,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"Avenda Health AI Prostate Cancer Planning Software","Avenda Health, Inc.","2022-11-22",{"k_number":28,"device_name":225,"applicant":190,"decision_date":253,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"2021-12-16",{"k_number":18,"device_name":255,"applicant":256,"decision_date":257,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"Optellum Virtual Nodule Clinic, Optellum software, Optellum platform","Optellum, Ltd.","2021-03-05",{"k_number":20,"device_name":259,"applicant":260,"decision_date":261,"clearance_type":191,"decision_code":192,"statement_or_summary":193},"EchoGo Pro","Ultromics, Ltd.","2020-12-18",{"items":263,"total":65},[]]