[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-SGB":3},{"classification":4,"mappedDevices":30,"similarCandidates":31,"relatedClassifications":109,"syncDates":110,"translation":117,"marketSummary":124,"recalls":137,"k510s":139,"pmas":146},{"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},6712,"SGB","Pain Assessment Software In Non-Communicative Adults","2","882.1472","NE","Neurology","1","Pain assessment software in non-communicative adults is a prescription-only device that combines information from clinical pain domains to produce an output indicative of a patient’s current level of pain in conscious adult patients who are unable to communicate their current pain level. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic tool.",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],"DEN240073",[20],"3022518366",[20],"","N","Ineligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:48.758894+00:00",0,null,1,[],[32,41,48,56,64,72,79,87,95,103],{"medical_device_id":33,"generic_name":34,"class_classification":35,"jmdn_code":36,"name_similarity":37,"definition_similarity":38,"vector_similarity":39,"score":40},3067,"成人用肺機能分析装置用プログラム","Ⅱ","35282032",0.2,0.217949,0.686608,0.0325225,{"medical_device_id":42,"generic_name":43,"class_classification":35,"jmdn_code":44,"name_similarity":37,"definition_similarity":45,"vector_similarity":46,"score":47},3129,"非観血血圧モニタ用プログラム","31681012",0.194888,0.67643,0.03125,{"medical_device_id":49,"generic_name":50,"class_classification":51,"jmdn_code":52,"name_similarity":37,"definition_similarity":53,"vector_similarity":54,"score":55},1125,"植込み能動型機器管理用プログラム","Ⅲ","71052003",0.256532,0.656302,0.0310993,{"medical_device_id":57,"generic_name":58,"class_classification":35,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},3188,"歯科根管用治療支援プログラム","71073002",0.158537,0.264151,0.659952,0.0274972,{"medical_device_id":65,"generic_name":66,"class_classification":35,"jmdn_code":67,"name_similarity":68,"definition_similarity":69,"vector_similarity":70,"score":71},3056,"神経モニタ用プログラム","36081012",0.164384,0.236066,0.646898,0.0263889,{"medical_device_id":73,"generic_name":74,"class_classification":35,"jmdn_code":75,"name_similarity":76,"definition_similarity":77,"vector_similarity":78,"score":71},3114,"血圧脈波検査装置用プログラム","70045012",0.176471,0.204013,0.641528,{"medical_device_id":80,"generic_name":81,"class_classification":35,"jmdn_code":82,"name_similarity":83,"definition_similarity":84,"vector_similarity":85,"score":86},3059,"位置決定用神経探知刺激装置用プログラム","35723012",0.166667,0.19544,0.640995,0.0238129,{"medical_device_id":88,"generic_name":89,"class_classification":35,"jmdn_code":90,"name_similarity":91,"definition_similarity":92,"vector_similarity":93,"score":94},3144,"神経疾患診断用定量的感覚検査器用プログラム","37349012",0.142857,0.208589,0.685739,0.016129,{"medical_device_id":96,"generic_name":97,"class_classification":35,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":102},3086,"耳音響放射装置用プログラム","36908012",0.197531,0.215434,0.576096,0.015873,{"medical_device_id":104,"generic_name":105,"class_classification":35,"jmdn_code":106,"name_similarity":91,"definition_similarity":107,"vector_similarity":108,"score":102},3161,"呼吸装置治療支援プログラム","71040002",0.261146,0.677208,[],{"510k":111,"classification":112,"enforcement":113,"event":114,"pma":115,"warning_letter":116},"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":118,"definition_ja":119,"commentary_ja":120,"model_name":121,"source_hash":122,"reviewed_by":28,"reviewed_at":28,"created_at":123,"updated_at":123},"非コミュニケーション成人用疼痛評価ソフトウェア","非コミュニケーション成人用疼痛評価ソフトウェアとは、複数の臨床的疼痛領域からの情報を組み合わせて、自らの現在の疼痛レベルを伝えることができない意識のある成人患者における現在の疼痛レベルを示す出力を生成する、処方箋医療機器である。本機器は補助的使用を目的とするものであり、単独での診断用または予後予測用ツールとしての使用を意図するものではない。","本機器は米国においてクラス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。クラスIIは中程度のリスクを有する医療機器に適用される区分であり、既存の同等な機器（同等性比較対象）との実質的同等性を示すことで市販が可能となる510(k)手続きが用いられます。","claude-sonnet-5","294a334561482c5185a8891b83587c5825ee30604e11622e3b6664d95ba3b263","2026-08-24T03:40:21.731962+00:00",{"product_code":6,"summary_ja":125,"stats":126,"stats_hash":135,"model_name":121,"created_at":136,"updated_at":136},"510(k)の累計件数は1件で、参入企業数は1社、直近5年でも1件の実績があります。PMAの承認事例、不具合報告、回収については、いずれも確認されていません。",{"pma":127,"k510":128,"as_of":130,"events":131,"recalls":132,"top_problems":134},{"latest":28,"originals":27,"supplements":27},{"total":29,"last5y":29,"latest":129,"applicants":29},"2025-10-06","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":133},[],[],"5dfa061c8ff2966e0d968bf35d4a0631cb38dd4a4f6b53071c837ba6d442c506","2026-08-24T05:23:16.025025+00:00",{"items":138,"total":27},[],{"items":140,"total":29},[141],{"k_number":18,"device_name":142,"applicant":143,"decision_date":129,"clearance_type":144,"decision_code":145,"statement_or_summary":28},"PainChek  (PainChek Adult)","Painchek Limited (Ltd.)","Direct","DENG",{"items":147,"total":27},[]]