[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HJG":3},{"classification":4,"mappedDevices":48,"similarCandidates":49,"relatedClassifications":122,"syncDates":123,"translation":130,"marketSummary":136,"recalls":151,"k510s":153,"pmas":182},{"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":42,"updated_at":43,"recall_count":44,"latest_recall_date":45,"k510_count":46,"pma_count":44,"event_count":47},4152,"HJG","System, Reading, Television, Closed-Circuit","1","886.5820","OP","Ophthalmic","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":40,"product_code":6,"review_panel":10,"gmp_exempt_flag":40,"third_party_flag":40,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":40,"medical_specialty_description":11,"summary_malfunction_reporting":41},{"k_number":17,"fei_number":26,"registration_number":38},[18,19,20,21,22,23,24,25],"K920069","K915340","K892351","K892350","K892348","K892349","K933633","K892347",[27,28,29,30,31,32,33,34,35,36,37],"3009840810","3015769026","3011898560","3003951061","3003032840","1000158674","3014656175","2936829","3014656174","3011587055","3009330874",[27,28,39,29,30,31,33,34,35,36,37],"1123650","N","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-24T02:00:47.949024+00:00",0,null,8,1,[],[50,58,66,74,81,88,95,102,109,115],{"medical_device_id":51,"generic_name":52,"class_classification":53,"jmdn_code":54,"name_similarity":55,"definition_similarity":44,"vector_similarity":56,"score":57},789,"閉鎖循環式麻酔システム","Ⅲ","34432000",0.403846,0.620377,0.0315136,{"medical_device_id":59,"generic_name":60,"class_classification":61,"jmdn_code":62,"name_similarity":63,"definition_similarity":44,"vector_similarity":64,"score":65},3259,"X線用テレビ装置","Ⅰ","70027000",0.422222,0.613805,0.0310993,{"medical_device_id":67,"generic_name":68,"class_classification":69,"jmdn_code":70,"name_similarity":71,"definition_similarity":44,"vector_similarity":72,"score":73},1529,"テレメトリー式心拍陣痛計","Ⅱ","38479000",0.196721,0.582059,0.0240999,{"medical_device_id":75,"generic_name":76,"class_classification":61,"jmdn_code":77,"name_similarity":78,"definition_similarity":44,"vector_similarity":79,"score":80},3878,"手術台システム","37325000",0.188679,0.587345,0.0240219,{"medical_device_id":82,"generic_name":83,"class_classification":69,"jmdn_code":84,"name_similarity":85,"definition_similarity":44,"vector_similarity":86,"score":87},2434,"再使用可能な麻酔用呼吸回路","37021000",0.19697,0.578343,0.0239736,{"medical_device_id":89,"generic_name":90,"class_classification":61,"jmdn_code":91,"name_similarity":92,"definition_similarity":44,"vector_similarity":93,"score":94},3348,"心臓内心電計ケーブル及びスイッチ","35562020",0.0365854,0.630629,0.0163934,{"medical_device_id":96,"generic_name":97,"class_classification":69,"jmdn_code":98,"name_similarity":99,"definition_similarity":44,"vector_similarity":100,"score":101},1552,"テレメトリー式生体信号測定装置","32547000",0.1875,0.622527,0.016129,{"medical_device_id":103,"generic_name":104,"class_classification":69,"jmdn_code":105,"name_similarity":106,"definition_similarity":44,"vector_similarity":107,"score":108},3178,"閉鎖式薬剤移注システム","71055002",0.283019,0.560272,0.015873,{"medical_device_id":110,"generic_name":111,"class_classification":61,"jmdn_code":112,"name_similarity":113,"definition_similarity":44,"vector_similarity":114,"score":108},3985,"電気手術器用ケーブル及びスイッチ","70657000",0.0533333,0.620637,{"medical_device_id":116,"generic_name":117,"class_classification":53,"jmdn_code":118,"name_similarity":119,"definition_similarity":44,"vector_similarity":120,"score":121},723,"人工心肺用回路システム","70524100",0.280702,0.572186,0.015625,[],{"510k":124,"classification":125,"enforcement":126,"event":127,"pma":128,"warning_letter":129},"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":131,"definition_ja":45,"commentary_ja":132,"model_name":133,"source_hash":134,"reviewed_by":45,"reviewed_at":45,"created_at":135,"updated_at":135},"閉回路テレビ式拡大読書器","本機器は、視覚障害を持つ患者が文字や画像を拡大して見ることを支援する、閉回路テレビ方式の読書用システムです。米国ではクラスIに分類されており、リスクが低い機器として市販前届出（510(k)）が免除されています。","claude-sonnet-5","ef0e8569aef30e160f8108d009f4964d109c00b6cacf649b915460408383e001","2026-08-24T01:56:53.662172+00:00",{"product_code":6,"summary_ja":137,"stats":138,"stats_hash":149,"model_name":133,"created_at":150,"updated_at":150},"本製品コードでは、510(k)の累計届出件数は約8件、参入企業数は4社となっていますが、直近5年間の届出実績は確認されていません。不具合報告（MDR）は累計1件で、内容はいずれも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（リコール）については累計0件で、クラスI・II・IIIのいずれも報告されていません。",{"pma":139,"k510":140,"as_of":143,"events":144,"recalls":146,"top_problems":148},{"latest":45,"originals":44,"supplements":44},{"total":46,"last5y":44,"latest":141,"applicants":142},"1994-02-22",4,"2026-08",{"death":44,"other":44,"total":47,"injury":44,"last5y":44,"malfunction":47,"latest_month":145},"1994-04",{"total":44,"last5y":44,"latest":45,"class_i":44,"class_ii":44,"class_iii":44,"top_root_causes":147},[],[],"006dbc6d2f5d94853aa18bbe4011cc54611468e5fa75d06f8a4cd0834fe6193c","2026-08-24T04:32:35.506862+00:00",{"items":152,"total":44},[],{"items":154,"total":46},[155,161,165,170,174,176,178,180],{"k_number":24,"device_name":156,"applicant":157,"decision_date":141,"clearance_type":158,"decision_code":159,"statement_or_summary":160},"LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE","Gracefully Yours, Inc.","Traditional","SESE","Statement",{"k_number":19,"device_name":162,"applicant":163,"decision_date":164,"clearance_type":158,"decision_code":159,"statement_or_summary":160},"MENTOR HORIZON LOW VISION MAGNIFIER","Mentor O & O, Inc.","1992-03-30",{"k_number":18,"device_name":166,"applicant":167,"decision_date":168,"clearance_type":158,"decision_code":159,"statement_or_summary":169},"MAGNI-CAM","Innoventions, Inc.","1992-03-02","Summary",{"k_number":20,"device_name":171,"applicant":172,"decision_date":173,"clearance_type":158,"decision_code":159,"statement_or_summary":45},"MAGNILINK SYSTEM 602","Coburn Optical Ind., Inc.","1989-05-26",{"k_number":21,"device_name":175,"applicant":172,"decision_date":173,"clearance_type":158,"decision_code":159,"statement_or_summary":45},"MAGNILINK SYSTEM 402\u002F5",{"k_number":23,"device_name":177,"applicant":172,"decision_date":173,"clearance_type":158,"decision_code":159,"statement_or_summary":45},"MAGNILINK SYSTEM 209",{"k_number":22,"device_name":179,"applicant":172,"decision_date":173,"clearance_type":158,"decision_code":159,"statement_or_summary":45},"MAGNILINK SYSTEM 201",{"k_number":25,"device_name":181,"applicant":172,"decision_date":173,"clearance_type":158,"decision_code":159,"statement_or_summary":45},"MAGNILINK SYSTEM 101",{"items":183,"total":44},[]]