[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LHM":3},{"classification":4,"mappedDevices":26,"similarCandidates":27,"relatedClassifications":98,"syncDates":111,"translation":118,"marketSummary":124,"recalls":138,"k510s":140,"pmas":147},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":8,"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":23,"event_count":25},1257,"LHM","System, Thermographic, Liquid Crystal","1","884.2982","OB","Obstetrics\u002FGynecology","RA","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":19,"product_code":6,"review_panel":12,"gmp_exempt_flag":19,"third_party_flag":19,"medical_specialty":10,"regulation_number":9,"submission_type_id":8,"unclassified_reason":13,"life_sustain_support_flag":19,"medical_specialty_description":11,"summary_malfunction_reporting":20},{"k_number":17},[18],"K872962","N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:49.169481+00:00",0,null,1,[],[28,36,43,50,57,64,71,78,85,91],{"medical_device_id":29,"generic_name":30,"class_classification":31,"jmdn_code":32,"name_similarity":33,"definition_similarity":23,"vector_similarity":34,"score":35},1351,"電動式液晶サーモグラフィ装置","Ⅱ","40798002",0.711111,0.811383,0.0327869,{"medical_device_id":37,"generic_name":38,"class_classification":31,"jmdn_code":39,"name_similarity":40,"definition_similarity":23,"vector_similarity":41,"score":42},3096,"電動式液晶サーモグラフィ装置用プログラム","40798012",0.561404,0.806191,0.032002,{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":23,"vector_similarity":49,"score":42},3264,"液晶サーモグラフィシート","Ⅰ","40798001",0.642857,0.756041,{"medical_device_id":51,"generic_name":52,"class_classification":31,"jmdn_code":53,"name_similarity":54,"definition_similarity":23,"vector_similarity":55,"score":56},1349,"赤外線サーモグラフィ装置","40803000",0.391304,0.715391,0.03125,{"medical_device_id":58,"generic_name":59,"class_classification":31,"jmdn_code":60,"name_similarity":61,"definition_similarity":23,"vector_similarity":62,"score":63},1352,"マイクロ波サーモグラフィ装置","40802000",0.382979,0.704819,0.0307692,{"medical_device_id":65,"generic_name":66,"class_classification":31,"jmdn_code":67,"name_similarity":68,"definition_similarity":23,"vector_similarity":69,"score":70},1350,"サーモグラフィ装置オペレータ用コンソール","40972000",0.358491,0.667455,0.030303,{"medical_device_id":72,"generic_name":73,"class_classification":46,"jmdn_code":74,"name_similarity":75,"definition_similarity":23,"vector_similarity":76,"score":77},4447,"液体金属毛細管体温計","71091001",0.301887,0.666704,0.0298507,{"medical_device_id":79,"generic_name":80,"class_classification":31,"jmdn_code":81,"name_similarity":82,"definition_similarity":23,"vector_similarity":83,"score":84},1624,"定量的感覚検査用温度分析装置","37350000",0.185714,0.659135,0.0147059,{"medical_device_id":86,"generic_name":87,"class_classification":46,"jmdn_code":88,"name_similarity":89,"definition_similarity":23,"vector_similarity":90,"score":84},3390,"角膜トポグラフィーシステム","18038010",0.297872,0.60244,{"medical_device_id":92,"generic_name":93,"class_classification":31,"jmdn_code":94,"name_similarity":95,"definition_similarity":23,"vector_similarity":96,"score":97},1265,"デジタル式歯科用パノラマ・断層撮影X線診断装置","37669000",0.285714,0.581934,0.0144928,[99,104,108],{"product_code":100,"device_name":101,"device_class":102,"k510_count":103},"KXZ","System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)","3",7,{"product_code":105,"device_name":106,"device_class":8,"k510_count":107},"KYA","System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)",5,{"product_code":109,"device_name":110,"device_class":102,"k510_count":23},"LHR","System, Thermographic, Liquid Crystal (Sole Diagnostic Screen)",{"510k":112,"classification":113,"enforcement":114,"event":115,"pma":116,"warning_letter":117},"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":119,"definition_ja":24,"commentary_ja":120,"model_name":121,"source_hash":122,"reviewed_by":24,"reviewed_at":24,"created_at":123,"updated_at":123},"液晶式サーモグラフィシステム","本機器は、液晶material の温度変化に伴う色調変化を利用して体表面の温度分布を可視化し、婦人科領域などにおける診断補助情報を得るための装置です。米国ではクラスIに分類され、市販前届出（510(k)）の対象として、市販前に安全性及び有効性に関する基本的な情報を提出することが求められています。","claude-sonnet-5","5c46f564d4e82c7090c6ff299df4f5a59da1fc9533f7ac3dc009e553086bf51c","2026-08-24T02:11:36.699753+00:00",{"product_code":6,"summary_ja":125,"stats":126,"stats_hash":136,"model_name":121,"created_at":137,"updated_at":137},"本製品コードの510(k)届出は累計1件で、参入企業数は1社、直近5年間の届出はなく、最新の判定は1987年10月です。PMAによる承認実績は確認されていません。不具合報告は累計1件で、内訳は傷害が1件、死亡や不具合の報告はなく、最新の報告は2015年1月です。回収については累計0件で、クラスI・II・IIIいずれも確認されていません。",{"pma":127,"k510":128,"as_of":130,"events":131,"recalls":133,"top_problems":135},{"latest":24,"originals":23,"supplements":23},{"total":25,"last5y":23,"latest":129,"applicants":25},"1987-10-20","2026-08",{"death":23,"other":23,"total":25,"injury":25,"last5y":23,"malfunction":23,"latest_month":132},"2015-01",{"total":23,"last5y":23,"latest":24,"class_i":23,"class_ii":23,"class_iii":23,"top_root_causes":134},[],[],"3f8a1b3518bd3f90562f9c04cdcf6d724b66057ff7dc97a4027ec3709b71633e","2026-08-24T04:50:56.354429+00:00",{"items":139,"total":23},[],{"items":141,"total":25},[142],{"k_number":18,"device_name":143,"applicant":144,"decision_date":129,"clearance_type":145,"decision_code":146,"statement_or_summary":24},"BREAST-SCAN(TM)","Thermascan, Inc.","Traditional","SESE",{"items":148,"total":23},[]]