[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-MRS":3},{"classification":4,"mappedDevices":72,"similarCandidates":73,"relatedClassifications":144,"syncDates":156},{"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":65,"updated_at":66,"recall_count":67,"latest_recall_date":68,"k510_count":69,"pma_count":70,"event_count":71},5142,"MRS","Test System, Nicotine, Cotinine, Metabolites","1","862.3220","TX","Clinical Toxicology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":63,"product_code":6,"review_panel":10,"gmp_exempt_flag":63,"third_party_flag":63,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":63,"medical_specialty_description":11,"summary_malfunction_reporting":64},{"k_number":17,"fei_number":21,"registration_number":57},[18,19,20],"K963733","K030649","K021688",[13,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56],"3030648160","3001451797","3043127647","3012073813","3009238284","3032147516","3010939897","2245285","3012725363","3008517993","3021010433","3023322455","3004635103","3031823359","3002622685","3010220539","3008054239","3002800697","3042227943","3007606081","1000125596","3003917514","3005641941","3005670738","3009585529","3017904598","2020952","3000210620","3010934853","3013077867","3010800486","3010852191","3024463179","3027519599","1000306617",[13,22,24,25,58,26,27,28,29,59,30,31,60,32,61,33,34,35,36,37,62,38,39,40,41,43,44,46,47,48,50,51,52,53,54,55],"2030633","2029372","2027969","3005360469","1649661","N","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-18T22:05:38.961415+00:00",1,"2020-03-11",3,0,2,[],[74,82,89,96,104,111,118,125,132,138],{"medical_device_id":75,"generic_name":76,"class_classification":77,"jmdn_code":78,"name_similarity":79,"definition_similarity":70,"vector_similarity":80,"score":81},1808,"健康検診システム","Ⅱ","70178000",0.22807,0.648617,0.0325225,{"medical_device_id":83,"generic_name":84,"class_classification":77,"jmdn_code":85,"name_similarity":86,"definition_similarity":70,"vector_similarity":87,"score":88},1571,"基礎代謝測定装置","70081000",0.283019,0.631135,0.0322665,{"medical_device_id":90,"generic_name":91,"class_classification":77,"jmdn_code":92,"name_similarity":93,"definition_similarity":70,"vector_similarity":94,"score":95},1278,"核医学診断用検出器回転型SPECT装置","40642000",0.188406,0.584854,0.027032,{"medical_device_id":97,"generic_name":98,"class_classification":99,"jmdn_code":100,"name_similarity":101,"definition_similarity":70,"vector_similarity":102,"score":103},3572,"自動尿スクリーニングシステム","Ⅰ","30648000",0.172414,0.601338,0.026289,{"medical_device_id":105,"generic_name":106,"class_classification":77,"jmdn_code":107,"name_similarity":108,"definition_similarity":70,"vector_similarity":109,"score":110},1589,"核医学診断用キセノンガス管理システム","40908000",0.183099,0.579419,0.0246951,{"medical_device_id":112,"generic_name":113,"class_classification":77,"jmdn_code":114,"name_similarity":115,"definition_similarity":70,"vector_similarity":116,"score":117},3198,"禁煙治療補助システム","71087002",0.132353,0.645152,0.016129,{"medical_device_id":119,"generic_name":120,"class_classification":77,"jmdn_code":121,"name_similarity":122,"definition_similarity":70,"vector_similarity":123,"score":124},2556,"トレパンシステムコントロールユニット","43928000",0.226415,0.519481,0.015873,{"medical_device_id":126,"generic_name":127,"class_classification":99,"jmdn_code":128,"name_similarity":129,"definition_similarity":70,"vector_similarity":130,"score":131},3524,"カテコールアミン分析装置","35989000",0.0526316,0.619915,0.015625,{"medical_device_id":133,"generic_name":134,"class_classification":99,"jmdn_code":135,"name_similarity":136,"definition_similarity":70,"vector_similarity":137,"score":131},3874,"カラム手術台システム","36611000",0.2,0.452845,{"medical_device_id":139,"generic_name":140,"class_classification":77,"jmdn_code":141,"name_similarity":136,"definition_similarity":70,"vector_similarity":142,"score":143},1279,"核医学診断用リング型SPECT装置","40643000",0.530454,0.0153846,[145,149,153],{"product_code":146,"device_name":147,"device_class":8,"k510_count":148},"JKS","Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide",8,{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"MKU","Enzyme Immunoassay, Nicotine And Nicotine Metabolites",7,{"product_code":154,"device_name":155,"device_class":8,"k510_count":71},"JKT","Gas Chromatograph, Carbon-Monoxide",{"510k":157,"classification":158,"enforcement":159,"event":160,"pma":161,"warning_letter":162},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]