[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LDK":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":110,"syncDates":111,"recalls":118,"k510s":120,"pmas":158},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":9,"implant_flag":13,"life_sustain_support_flag":13,"gmp_exempt_flag":13,"raw":14,"created_at":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":33,"event_count":36},5215,"LDK","Device, Sensing, Optical Contour","U","","Unknown","PM","7",false,{"openfda":15,"definition":9,"device_name":7,"review_code":9,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":11,"gmp_exempt_flag":28,"third_party_flag":28,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":29,"life_sustain_support_flag":28,"medical_specialty_description":10,"summary_malfunction_reporting":30},{"k_number":16,"fei_number":25,"registration_number":27},[17,18,19,20,21,22,23,24],"K230463","K232023","K800591","K851133","K923792","K844736","K183485","K860225",[26],"3029900922",[26],"N","1","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-18T22:05:38.961415+00:00",0,null,8,1,[],[39,47,53,60,67,74,82,90,97,103],{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":33,"vector_similarity":45,"score":46},1788,"内視鏡挿入形状検出装置","Ⅱ","70161000",0.3125,0.722507,0.0325225,{"medical_device_id":48,"generic_name":49,"class_classification":42,"jmdn_code":50,"name_similarity":51,"definition_similarity":33,"vector_similarity":52,"score":46},3148,"内視鏡挿入形状検出装置用プログラム","70161012",0.271186,0.738454,{"medical_device_id":54,"generic_name":55,"class_classification":42,"jmdn_code":56,"name_similarity":57,"definition_similarity":33,"vector_similarity":58,"score":59},2597,"光学式う蝕検出装置","33995020",0.25,0.696353,0.0310096,{"medical_device_id":61,"generic_name":62,"class_classification":42,"jmdn_code":63,"name_similarity":64,"definition_similarity":33,"vector_similarity":65,"score":66},2596,"光学的歯石歯垢検出器","33995010",0.211538,0.713953,0.0295716,{"medical_device_id":68,"generic_name":69,"class_classification":70,"jmdn_code":71,"name_similarity":57,"definition_similarity":33,"vector_similarity":72,"score":73},253,"強膜バックリング用器具","Ⅳ","15794000",0.544718,0.015873,{"medical_device_id":75,"generic_name":76,"class_classification":77,"jmdn_code":78,"name_similarity":79,"definition_similarity":33,"vector_similarity":80,"score":81},3403,"近点距離計","Ⅰ","12821000",0.0789474,0.705131,0.015625,{"medical_device_id":83,"generic_name":84,"class_classification":85,"jmdn_code":86,"name_similarity":87,"definition_similarity":33,"vector_similarity":88,"score":89},808,"能動型機器接続用酸素濃縮器","Ⅲ","12873003",0.24,0.504852,0.0153846,{"medical_device_id":91,"generic_name":92,"class_classification":85,"jmdn_code":93,"name_similarity":94,"definition_similarity":33,"vector_similarity":95,"score":96},840,"遠隔照射式治療用放射性核種システム向け輪郭探知器","36499000",0.13253,0.696127,0.0151515,{"medical_device_id":98,"generic_name":99,"class_classification":42,"jmdn_code":100,"name_similarity":101,"definition_similarity":33,"vector_similarity":102,"score":96},2314,"能動型機器接続歯科用シリンジ","35970012",0.236364,0.491457,{"medical_device_id":104,"generic_name":105,"class_classification":42,"jmdn_code":106,"name_similarity":107,"definition_similarity":33,"vector_similarity":108,"score":109},2188,"連続流式フラッシュデバイス","70383000",0.234043,0.508087,0.0149254,[],{"510k":112,"classification":113,"enforcement":114,"event":115,"pma":116,"warning_letter":117},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00",{"items":119,"total":33},[],{"items":121,"total":35},[122,129,133,137,142,146,150,154],{"k_number":17,"device_name":123,"applicant":124,"decision_date":125,"clearance_type":126,"decision_code":127,"statement_or_summary":128},"NSite Scoliosis Assessment App","Nsite, Inc.","2023-11-15","Traditional","SESE","Summary",{"k_number":18,"device_name":130,"applicant":131,"decision_date":132,"clearance_type":126,"decision_code":127,"statement_or_summary":128},"Momentum Spine","Momentum Health, Inc.","2023-10-04",{"k_number":23,"device_name":134,"applicant":135,"decision_date":136,"clearance_type":126,"decision_code":127,"statement_or_summary":128},"CryoVizion System","Cryos Technologies, Inc.","2019-08-28",{"k_number":21,"device_name":138,"applicant":139,"decision_date":140,"clearance_type":126,"decision_code":127,"statement_or_summary":141},"QUANTEC SPINAL MEASUEMENT SYSTEM","Quantec Image Processing , Ltd.","1994-04-20","Statement",{"k_number":24,"device_name":143,"applicant":144,"decision_date":145,"clearance_type":126,"decision_code":127,"statement_or_summary":34},"METRICOM","Far Orthopedics, Inc.","1986-02-11",{"k_number":20,"device_name":147,"applicant":148,"decision_date":149,"clearance_type":126,"decision_code":127,"statement_or_summary":34},"TERRAN BIOMECHANICAL ANALYSIS SYSTEM","Terran Biomedical Instruments","1985-06-19",{"k_number":22,"device_name":151,"applicant":152,"decision_date":153,"clearance_type":126,"decision_code":127,"statement_or_summary":34},"ISIS","Oxford Medilog, Inc.","1985-03-21",{"k_number":19,"device_name":155,"applicant":156,"decision_date":157,"clearance_type":126,"decision_code":127,"statement_or_summary":34},"CONTOUROGRAPH M-500","Bio-Tek Instruments, Inc.","1980-04-02",{"items":159,"total":33},[]]