[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FTZ":3},{"classification":4,"mappedDevices":39,"similarCandidates":40,"relatedClassifications":113,"syncDates":118,"translation":125,"marketSummary":131,"recalls":147,"k510s":149,"pmas":160},{"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":34,"updated_at":35,"recall_count":36,"latest_recall_date":37,"k510_count":38,"pma_count":36,"event_count":38},3287,"FTZ","Locator, Magnetic","1","886.4445","OP","Ophthalmic","4","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":31,"product_code":6,"review_panel":10,"gmp_exempt_flag":32,"third_party_flag":31,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":31,"medical_specialty_description":11,"summary_malfunction_reporting":33},{"k_number":18,"fei_number":21,"registration_number":27},[19,20],"K833229","K830468",[22,23,24,25,26],"3002750084","1421101","3010041511","3006509795","3005747797",[28,23,24,29,30],"1836161","8030607","3011137372","N","Y","Eligible","2026-08-18T05:52:50.955415+00:00","2026-08-24T02:00:48.225237+00:00",0,null,2,[],[41,49,56,63,70,77,84,91,99,106],{"medical_device_id":42,"generic_name":43,"class_classification":44,"jmdn_code":45,"name_similarity":46,"definition_similarity":36,"vector_similarity":47,"score":48},2007,"尿管ロケータ","Ⅱ","70265000",0.307692,0.67607,0.0320184,{"medical_device_id":50,"generic_name":51,"class_classification":44,"jmdn_code":52,"name_similarity":53,"definition_similarity":36,"vector_similarity":54,"score":55},2592,"歯科用根管長測定器","16355000",0.322581,0.669512,0.031746,{"medical_device_id":57,"generic_name":58,"class_classification":44,"jmdn_code":59,"name_similarity":60,"definition_similarity":36,"vector_similarity":61,"score":62},1626,"単回使用神経ロケータ","70099000",0.235294,0.675703,0.0306218,{"medical_device_id":64,"generic_name":65,"class_classification":44,"jmdn_code":66,"name_similarity":67,"definition_similarity":36,"vector_similarity":68,"score":69},1622,"位置決定用神経探知刺激装置","35723002",0.258065,0.65749,0.0305504,{"medical_device_id":71,"generic_name":72,"class_classification":44,"jmdn_code":73,"name_similarity":74,"definition_similarity":36,"vector_similarity":75,"score":76},1381,"心磁計","70047000",0.241379,0.593417,0.0284045,{"medical_device_id":78,"generic_name":79,"class_classification":44,"jmdn_code":80,"name_similarity":81,"definition_similarity":36,"vector_similarity":82,"score":83},2816,"歯科用精密磁性アタッチメント","38578000",0.204545,0.601822,0.0281914,{"medical_device_id":85,"generic_name":86,"class_classification":44,"jmdn_code":87,"name_similarity":88,"definition_similarity":36,"vector_similarity":89,"score":90},1460,"磁気刺激装置","36902000",0.48,0.567032,0.0280214,{"medical_device_id":92,"generic_name":93,"class_classification":94,"jmdn_code":95,"name_similarity":96,"definition_similarity":36,"vector_similarity":97,"score":98},3823,"眼内異物除去用磁石","Ⅰ","35495000",0.183673,0.643132,0.0278846,{"medical_device_id":100,"generic_name":101,"class_classification":44,"jmdn_code":102,"name_similarity":103,"definition_similarity":36,"vector_similarity":104,"score":105},1383,"筋磁計","70049000",0.222222,0.590492,0.0277992,{"medical_device_id":107,"generic_name":108,"class_classification":44,"jmdn_code":109,"name_similarity":110,"definition_similarity":36,"vector_similarity":111,"score":112},3059,"位置決定用神経探知刺激装置用プログラム","35723012",0.190476,0.603249,0.0273641,[114],{"product_code":115,"device_name":116,"device_class":8,"k510_count":117},"HPN","Magnet, Permanent",5,{"510k":119,"classification":120,"enforcement":121,"event":122,"pma":123,"warning_letter":124},"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":126,"definition_ja":37,"commentary_ja":127,"model_name":128,"source_hash":129,"reviewed_by":37,"reviewed_at":37,"created_at":130,"updated_at":130},"磁性体探知装置","本品は米国FDAの規制上クラスIに分類される眼科用機器であり、体内に存在する磁性を帯びた異物の位置を検出するために用いられる装置です。米国においてクラスIの機器は一般に人体へのリスクが低いとされ、本品は市販前届出（510(k)）が免除される区分に該当します。","claude-sonnet-5","4b877b954d5e49c8e94b55092cfd1c87f7fbbd8e886a80e38261bdb42d4a29be","2026-08-24T01:52:15.787179+00:00",{"product_code":6,"summary_ja":132,"stats":133,"stats_hash":145,"model_name":128,"created_at":146,"updated_at":146},"本製品区分は届出免除の対象であり、510(k)は累計2件で、直近5年の新規届出は確認されていません。不具合報告は累計2件と少なく、内容はいずれもMalfunction（不具合）で、主な問題としてMechanical Problem（機械的問題）が挙げられています。回収については累計件数が0件であり、確認されていません。",{"pma":134,"k510":135,"as_of":137,"events":138,"recalls":141,"top_problems":143},{"latest":37,"originals":36,"supplements":36},{"total":38,"last5y":36,"latest":136,"applicants":38},"1984-01-27","2026-08",{"death":36,"other":36,"total":38,"injury":36,"last5y":139,"malfunction":38,"latest_month":140},1,"2022-04",{"total":36,"last5y":36,"latest":37,"class_i":36,"class_ii":36,"class_iii":36,"top_root_causes":142},[],[144],"Mechanical Problem","880b9f8d48da33831aa351c22502acee722f97d2b80c6047979c0ebfe8daad98","2026-08-24T04:25:47.269073+00:00",{"items":148,"total":36},[],{"items":150,"total":38},[151,156],{"k_number":19,"device_name":152,"applicant":153,"decision_date":136,"clearance_type":154,"decision_code":155,"statement_or_summary":37},"SUN BED BY VERRE ET QUARTZ UVA-FRANCE","H & M Douglas Enterprises, Inc.","Traditional","SESE",{"k_number":20,"device_name":157,"applicant":158,"decision_date":159,"clearance_type":154,"decision_code":155,"statement_or_summary":37},"MODEL 200","Western Laboratories Corp.","1983-04-12",{"items":161,"total":36},[]]