[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-JJO":3},{"classification":4,"mappedDevices":50,"similarCandidates":51,"relatedClassifications":121,"syncDates":122,"translation":129,"marketSummary":135,"recalls":149,"k510s":151,"pmas":220},{"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":45,"updated_at":46,"recall_count":47,"latest_recall_date":48,"k510_count":49,"pma_count":47,"event_count":47},157,"JJO","Flame Emission Photometer For Clinical Use","1","862.2540","CH","Clinical Chemistry","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":43,"product_code":6,"review_panel":10,"gmp_exempt_flag":43,"third_party_flag":43,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":43,"medical_specialty_description":11,"summary_malfunction_reporting":44},{"k_number":17,"fei_number":40,"registration_number":42},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"K862148","K771337","K823480","K792087","K780650","K833535","K820631","K873603","K841422","K832937","K832936","K832886","K770393","K840530","K780649","K841847","K840044","K832932","K841421","K834226","K843375","K832931",[41],"3006198300",[41],"N","Eligible","2026-08-18T05:52:47.660896+00:00","2026-08-24T02:00:48.095002+00:00",0,null,22,[],[52,60,67,74,82,88,95,101,108,114],{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":47,"vector_similarity":58,"score":59},3496,"炎光式電解質分析装置","Ⅰ","35826000",0.295082,0.684521,0.0325225,{"medical_device_id":61,"generic_name":62,"class_classification":55,"jmdn_code":63,"name_similarity":64,"definition_similarity":47,"vector_similarity":65,"score":66},3527,"ポータブル臨床用屈折計","37034000",0.275862,0.652361,0.029116,{"medical_device_id":68,"generic_name":69,"class_classification":55,"jmdn_code":70,"name_similarity":71,"definition_similarity":47,"vector_similarity":72,"score":73},3533,"体外検査用オキシメータ","15201000",0.0714286,0.723145,0.0163934,{"medical_device_id":75,"generic_name":76,"class_classification":77,"jmdn_code":78,"name_similarity":79,"definition_similarity":47,"vector_similarity":80,"score":81},1563,"黄疸計","Ⅱ","70078000",0.104167,0.681975,0.015873,{"medical_device_id":83,"generic_name":84,"class_classification":55,"jmdn_code":85,"name_similarity":86,"definition_similarity":47,"vector_similarity":87,"score":81},3486,"フロー方式臨床化学分析装置","35745010",0.233333,0.592311,{"medical_device_id":89,"generic_name":90,"class_classification":77,"jmdn_code":91,"name_similarity":92,"definition_similarity":47,"vector_similarity":93,"score":94},1426,"膀胱検査用超音波プローブ","37804000",0.213115,0.595528,0.015625,{"medical_device_id":96,"generic_name":97,"class_classification":55,"jmdn_code":98,"name_similarity":99,"definition_similarity":47,"vector_similarity":100,"score":94},3494,"汎用分光光度分析装置","36910000",0.131579,0.678544,{"medical_device_id":102,"generic_name":103,"class_classification":77,"jmdn_code":104,"name_similarity":105,"definition_similarity":47,"vector_similarity":106,"score":107},3091,"経皮血液ガスセンサ・パルスオキシメータプローブ組合せ生体現象監視用機器用プログラム","17148002",0.0977444,0.676919,0.0153846,{"medical_device_id":109,"generic_name":110,"class_classification":55,"jmdn_code":111,"name_similarity":112,"definition_similarity":47,"vector_similarity":113,"score":107},3487,"移動式フロー方式臨床化学分析装置","35745020",0.208955,0.601644,{"medical_device_id":115,"generic_name":116,"class_classification":77,"jmdn_code":117,"name_similarity":118,"definition_similarity":47,"vector_similarity":119,"score":120},1570,"機能検査オキシメータ","70080000",0.127273,0.669281,0.0151515,[],{"510k":123,"classification":124,"enforcement":125,"event":126,"pma":127,"warning_letter":128},"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":130,"definition_ja":48,"commentary_ja":131,"model_name":132,"source_hash":133,"reviewed_by":48,"reviewed_at":48,"created_at":134,"updated_at":134},"臨床用炎光光度計","本機器は、試料を火炎中で燃焼させた際に放出される光の波長や強度を測定し、ナトリウムやカリウムなどの元素濃度を定量する臨床化学検査用の分析装置です。米国ではクラスIに分類されており、市販前届出（510(k)）が免除される区分とされています。これはリスクが比較的低い機器であることを示しており、市販前の個別審査を経ずに流通させることが認められています。","claude-sonnet-5","5d276194f4ec8f03cb11c1e20c5b924b3e92f18bdc5faed485a70a6cbe95d89f","2026-08-24T02:01:22.211969+00:00",{"product_code":6,"summary_ja":136,"stats":137,"stats_hash":147,"model_name":132,"created_at":148,"updated_at":148},"本製品コードは510(k)累計約20件、参入企業数12社となっていますが、直近5年間の届出はなく、最新の判定は1987年9月にとどまります。PMAの承認実績は確認されていません。不具合報告および回収については、いずれも累計0件で確認されていません。",{"pma":138,"k510":139,"as_of":142,"events":143,"recalls":144,"top_problems":146},{"latest":48,"originals":47,"supplements":47},{"total":49,"last5y":47,"latest":140,"applicants":141},"1987-09-22",12,"2026-08",{"death":47,"other":47,"total":47,"injury":47,"last5y":47,"malfunction":47,"latest_month":48},{"total":47,"last5y":47,"latest":48,"class_i":47,"class_ii":47,"class_iii":47,"top_root_causes":145},[],[],"639e57451b811b7c13064d23db72af34330ed25537f4cb3c7895b529decde26c","2026-08-24T04:40:52.092694+00:00",{"items":150,"total":47},[],{"items":152,"total":49},[153,158,162,166,170,174,177,179,183,187,190,194,197,199,201,203,207,211,215,218],{"k_number":25,"device_name":154,"applicant":155,"decision_date":140,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"FINNIGAN MAT INCOS 50","Finnigan Corp.","Traditional","SESE",{"k_number":18,"device_name":159,"applicant":160,"decision_date":161,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"OLYMPUS AU 5000 FLAME PHOTOMETER MODULE","Olympus Corp.","1986-09-29",{"k_number":38,"device_name":163,"applicant":164,"decision_date":165,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"ELVI 655 FLAME PHOTOMETER","Logos Scientific, Inc.","1985-05-20",{"k_number":33,"device_name":167,"applicant":168,"decision_date":169,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"LITHIUM REAGENT","Reagent Laboratory, Inc.","1984-08-17",{"k_number":37,"device_name":171,"applicant":172,"decision_date":173,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"FLAME PHOTOMETERS","Dr. Bruno Lange GmbH","1984-06-22",{"k_number":26,"device_name":175,"applicant":168,"decision_date":176,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"VOLUME TEST DYE 6","1984-05-11",{"k_number":36,"device_name":178,"applicant":168,"decision_date":176,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"DAILY WASH SOLUTION 5",{"k_number":31,"device_name":180,"applicant":181,"decision_date":182,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"SUPPLIES FOR INSTRUMENTATION LAB FLAME","Shaban Mfg. Co.","1984-03-30",{"k_number":34,"device_name":184,"applicant":185,"decision_date":186,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"SDI PREPAX DILUKIT 29-1000","Scientific Distributors, Inc.","1984-03-09",{"k_number":23,"device_name":188,"applicant":181,"decision_date":189,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"POTASSIUM SODIUM ANALYSIS PRODUCTS","1983-12-29",{"k_number":29,"device_name":191,"applicant":192,"decision_date":193,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"FLAME PHOTOMETER T281-T282-T283","Texas Intl. Laboratories, Inc.","1983-12-08",{"k_number":27,"device_name":195,"applicant":181,"decision_date":196,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"SHABAN #9868 TUBING KIT-9870 STYLET","1983-10-14",{"k_number":28,"device_name":198,"applicant":181,"decision_date":196,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"SHABAN #9850 PUMP WINDINGS-9860 FILTER",{"k_number":35,"device_name":200,"applicant":181,"decision_date":196,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"SHABAN #9858 ASPIRATOR ASSEMBLE #9862-",{"k_number":39,"device_name":202,"applicant":181,"decision_date":196,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"SHABAN #9852 CHIMNEY-#9854 SCREEN &",{"k_number":20,"device_name":204,"applicant":205,"decision_date":206,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"IL 943 FLAME PHOTOMETER","Instrumentation Laboratory CO","1983-01-09",{"k_number":24,"device_name":208,"applicant":209,"decision_date":210,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"CORNING 480 FLAME PHOTOMETER","Corning Medical & Scientific","1982-04-01",{"k_number":21,"device_name":212,"applicant":213,"decision_date":214,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"MICROFLAME PHOTOMETER","Gilford Instrument Laboratories, Inc.","1979-11-13",{"k_number":22,"device_name":216,"applicant":209,"decision_date":217,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"FLAME PHOTOMETER, MODEL 455","1978-05-26",{"k_number":32,"device_name":219,"applicant":209,"decision_date":217,"clearance_type":156,"decision_code":157,"statement_or_summary":48},"FLAME PHOTOMETER, MODEL 435",{"items":221,"total":47},[]]