[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-JQZ":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":104,"syncDates":180,"translation":187,"marketSummary":193,"recalls":206,"k510s":208,"pmas":215},{"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":15,"raw":16,"created_at":27,"updated_at":28,"recall_count":29,"latest_recall_date":30,"k510_count":31,"pma_count":29,"event_count":29},4861,"JQZ","Polarimeter","1","862.2050","CH","Clinical Chemistry","4","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":24,"product_code":6,"review_panel":10,"gmp_exempt_flag":25,"third_party_flag":24,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":24,"medical_specialty_description":11,"summary_malfunction_reporting":26},{"k_number":18,"fei_number":20,"registration_number":22},[19],"K811263",[21],"3009662620",[23],"8030433","N","Y","Eligible","2026-08-18T05:52:52.082407+00:00","2026-08-24T02:00:48.882786+00:00",0,null,1,[],[34,42,49,56,63,69,76,83,90,97],{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":29,"vector_similarity":40,"score":41},3386,"平面視野計","Ⅰ","34968000",0.277778,0.676183,0.0317781,{"medical_device_id":43,"generic_name":44,"class_classification":37,"jmdn_code":45,"name_similarity":46,"definition_similarity":29,"vector_similarity":47,"score":48},3403,"近点距離計","12821000",0.222222,0.609885,0.0296703,{"medical_device_id":50,"generic_name":51,"class_classification":37,"jmdn_code":52,"name_similarity":53,"definition_similarity":29,"vector_similarity":54,"score":55},4399,"瞳孔計","13236000",0.25,0.584585,0.0278097,{"medical_device_id":57,"generic_name":58,"class_classification":37,"jmdn_code":59,"name_similarity":60,"definition_similarity":29,"vector_similarity":61,"score":62},4380,"不等像視診断計","11391000",0.2,0.611401,0.0273897,{"medical_device_id":64,"generic_name":65,"class_classification":37,"jmdn_code":66,"name_similarity":60,"definition_similarity":29,"vector_similarity":67,"score":68},3533,"体外検査用オキシメータ","15201000",0.606507,0.026289,{"medical_device_id":70,"generic_name":71,"class_classification":37,"jmdn_code":72,"name_similarity":73,"definition_similarity":29,"vector_similarity":74,"score":75},3422,"捻転角度計","35408000",0.210526,0.575349,0.0244813,{"medical_device_id":77,"generic_name":78,"class_classification":79,"jmdn_code":80,"name_similarity":60,"definition_similarity":29,"vector_similarity":81,"score":82},348,"脳オキシメータ","Ⅲ","17942000",0.584831,0.0240565,{"medical_device_id":84,"generic_name":85,"class_classification":86,"jmdn_code":87,"name_similarity":73,"definition_similarity":29,"vector_similarity":88,"score":89},1563,"黄疸計","Ⅱ","70078000",0.575222,0.0240219,{"medical_device_id":91,"generic_name":92,"class_classification":86,"jmdn_code":93,"name_similarity":94,"definition_similarity":29,"vector_similarity":95,"score":96},1521,"パルスオキシメータ","17148010",0.285714,0.564614,0.0163934,{"medical_device_id":98,"generic_name":99,"class_classification":37,"jmdn_code":100,"name_similarity":101,"definition_similarity":29,"vector_similarity":102,"score":103},3384,"自動視野計","16918001",0.28,0.528766,0.016129,[105,109,113,117,120,124,128,132,136,139,143,146,149,152,156,159,162,165,168,171,174,177],{"product_code":106,"device_name":107,"device_class":8,"k510_count":108},"JQC","Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use",38,{"product_code":110,"device_name":111,"device_class":8,"k510_count":112},"JRL","Unit, Filter, Membrane",9,{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"JQY","Ph Meter",8,{"product_code":118,"device_name":119,"device_class":8,"k510_count":116},"JRQ","Shaker\u002FStirrer",{"product_code":121,"device_name":122,"device_class":8,"k510_count":123},"JRM","Freezer",7,{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"JRC","Micro Pipette",6,{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"GLE","Mixer, Blood Tube",5,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"JRI","Cuvette, Thermostated",4,{"product_code":137,"device_name":138,"device_class":8,"k510_count":135},"JRR","Regulator, Temperature",{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"JJP","Electrode, Ion Selective (Non-Specified)",3,{"product_code":144,"device_name":145,"device_class":8,"k510_count":142},"JRG","Block, Heating",{"product_code":147,"device_name":148,"device_class":8,"k510_count":142},"LCI","Automated Radioimmunoassay Systems, For Clinical Use",{"product_code":150,"device_name":151,"device_class":8,"k510_count":142},"LXG","Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use",{"product_code":153,"device_name":154,"device_class":8,"k510_count":155},"QBV","Centrifuge For Preparation Of Cell Concentrate And\u002FOr Plasma Concentrate",2,{"product_code":157,"device_name":158,"device_class":8,"k510_count":31},"JQQ","Dialyzer",{"product_code":160,"device_name":161,"device_class":8,"k510_count":31},"JRJ","Unit, Drying",{"product_code":163,"device_name":164,"device_class":8,"k510_count":29},"JBS","Timer, General Laboratory",{"product_code":166,"device_name":167,"device_class":8,"k510_count":29},"JQO","Balance, Analytical",{"product_code":169,"device_name":170,"device_class":8,"k510_count":29},"JRB","Micro Mixer",{"product_code":172,"device_name":173,"device_class":8,"k510_count":29},"JRK","Evaporator",{"product_code":175,"device_name":176,"device_class":8,"k510_count":29},"JRO","Blender\u002FMixer",{"product_code":178,"device_name":179,"device_class":8,"k510_count":29},"JRS","Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)",{"510k":181,"classification":182,"enforcement":183,"event":184,"pma":185,"warning_letter":186},"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":188,"definition_ja":30,"commentary_ja":189,"model_name":190,"source_hash":191,"reviewed_by":30,"reviewed_at":30,"created_at":192,"updated_at":192},"旋光計","本品は臨床化学分野において検体中の光学活性物質による旋光度を測定するための機器です。米国ではクラスIに分類されており、510(k)による市販前届出も免除されています。","claude-sonnet-5","d89fcf9fb5e0e1283ea4aeb5cefd5f904aaa639dea8d0ae62b3b7660c4d5ce3a","2026-08-24T02:04:16.411968+00:00",{"product_code":6,"summary_ja":194,"stats":195,"stats_hash":204,"model_name":190,"created_at":205,"updated_at":205},"本製品はクラスIかつ届出免除の機器であり、510(k)の累計件数は1件で、直近5年の届出はありません。不具合報告および回収については、いずれも累計件数が0件で、報告・実施例は確認されていません。",{"pma":196,"k510":197,"as_of":199,"events":200,"recalls":201,"top_problems":203},{"latest":30,"originals":29,"supplements":29},{"total":31,"last5y":29,"latest":198,"applicants":31},"1981-05-29","2026-08",{"death":29,"other":29,"total":29,"injury":29,"last5y":29,"malfunction":29,"latest_month":30},{"total":29,"last5y":29,"latest":30,"class_i":29,"class_ii":29,"class_iii":29,"top_root_causes":202},[],[],"d23f921a112c360f13a700e802f8faaf0995a58f46d2d47b62727ae1bca3ec79","2026-08-24T04:43:14.552546+00:00",{"items":207,"total":29},[],{"items":209,"total":31},[210],{"k_number":19,"device_name":211,"applicant":212,"decision_date":198,"clearance_type":213,"decision_code":214,"statement_or_summary":30},"TOX TM ANALYZER","Abbott Laboratories","Traditional","SESE",{"items":216,"total":29},[]]