[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-RCL":3},{"classification":4,"mappedDevices":22,"similarCandidates":23,"relatedClassifications":105,"syncDates":106,"translation":113,"marketSummary":120,"recalls":134,"k510s":136,"pmas":138},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":9,"submission_type_id":9,"definition":11,"implant_flag":12,"life_sustain_support_flag":12,"gmp_exempt_flag":13,"raw":14,"created_at":18,"updated_at":19,"recall_count":20,"latest_recall_date":12,"k510_count":20,"pma_count":20,"event_count":21},4566,"RCL","Ion Beam Implanter","N","","Unknown","An electronic system that implants ions for fabrication of semiconductor materials.",null,true,{"openfda":15,"definition":11,"device_name":7,"review_code":9,"device_class":8,"implant_flag":9,"product_code":6,"review_panel":9,"gmp_exempt_flag":16,"third_party_flag":9,"medical_specialty":9,"regulation_number":9,"submission_type_id":9,"unclassified_reason":9,"life_sustain_support_flag":9,"medical_specialty_description":10,"summary_malfunction_reporting":17},{},"Y","Ineligible","2026-08-18T05:52:52.082407+00:00","2026-08-24T02:00:48.095002+00:00",0,1,[],[24,33,41,50,58,65,73,82,90,97],{"medical_device_id":25,"generic_name":26,"class_classification":27,"jmdn_code":28,"name_similarity":29,"definition_similarity":30,"vector_similarity":31,"score":32},584,"体内固定用ボルト","Ⅲ","16077003",0.294118,0.103448,0.648013,0.0297619,{"medical_device_id":34,"generic_name":35,"class_classification":27,"jmdn_code":36,"name_similarity":37,"definition_similarity":38,"vector_similarity":39,"score":40},1046,"歯科用インプラントシステム","70909000",0.212121,0.297297,0.682059,0.0297268,{"medical_device_id":42,"generic_name":43,"class_classification":44,"jmdn_code":45,"name_similarity":46,"definition_similarity":47,"vector_similarity":48,"score":49},142,"体内植込み用カテーテル","Ⅳ","70384000",0.3,0.181818,0.645975,0.0295513,{"medical_device_id":51,"generic_name":52,"class_classification":27,"jmdn_code":53,"name_similarity":54,"definition_similarity":55,"vector_similarity":56,"score":57},1037,"歯科用骨再建インプラント材","34006009",0.211538,0.203209,0.640489,0.0238636,{"medical_device_id":59,"generic_name":60,"class_classification":27,"jmdn_code":61,"name_similarity":20,"definition_similarity":62,"vector_similarity":63,"score":64},878,"線形加速器システム","35159000",0.118694,0.67969,0.016129,{"medical_device_id":66,"generic_name":67,"class_classification":68,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":64},2025,"塞栓形成インプラント挿入器","Ⅱ","43978000",0.305556,0.131915,0.635228,{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},3498,"イオン選択性分析装置","Ⅰ","35902000",0.138889,0.152174,0.670679,0.015873,{"medical_device_id":83,"generic_name":84,"class_classification":27,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},601,"体内固定用ワッシャ","36198003",0.277778,0.103774,0.63631,0.015625,{"medical_device_id":91,"generic_name":92,"class_classification":76,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":89},4105,"歯科インプラント技工用器材","70757000",0.142857,0.240602,0.668932,{"medical_device_id":98,"generic_name":99,"class_classification":27,"jmdn_code":100,"name_similarity":101,"definition_similarity":102,"vector_similarity":103,"score":104},609,"体内固定用ケーブル","70504000",0.272727,0.125,0.590657,0.0153846,[],{"510k":107,"classification":108,"enforcement":109,"event":110,"pma":111,"warning_letter":112},"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":114,"definition_ja":115,"commentary_ja":116,"model_name":117,"source_hash":118,"reviewed_by":12,"reviewed_at":12,"created_at":119,"updated_at":119},"イオンビーム注入装置","半導体材料の製造のためにイオンを注入する電子システムである。","この機器は半導体材料の加工工程で用いられる産業用の装置であり、患者の診断や治療に直接使用される医療機器ではありません。米国FDAの分類上は「分類対象外（Not classified）」とされており、クラスI〜IIIのいずれにも該当せず、510(k)やPMAといった医療機器としての市販前審査の対象にはなっていません。","claude-sonnet-5","dd9698cbfaf6bcdd99399e5b51f1b45753b1e44e61ec1f23d8f8d9c7783f89cb","2026-08-24T03:37:43.881155+00:00",{"product_code":6,"summary_ja":121,"stats":122,"stats_hash":132,"model_name":117,"created_at":133,"updated_at":133},"本製品コードについては、510(k)およびPMAの届出・承認実績、ならびに回収の記録は確認されていません。不具合報告は累計約1件のみで、死亡・傷害・不具合のいずれにも該当しない「その他」の報告として、2022年2月に主な問題として「デバイス操作上の問題（Device Operational Issue）」が挙げられています。",{"pma":123,"k510":124,"as_of":125,"events":126,"recalls":128,"top_problems":130},{"latest":12,"originals":20,"supplements":20},{"total":20,"last5y":20,"latest":12,"applicants":20},"2026-08",{"death":20,"other":21,"total":21,"injury":20,"last5y":21,"malfunction":20,"latest_month":127},"2022-02",{"total":20,"last5y":20,"latest":12,"class_i":20,"class_ii":20,"class_iii":20,"top_root_causes":129},[],[131],"Device Operational Issue","bd6f4e66f8218804271233babdb0151c1db5ae6e639487ac3e5f55767856de5a","2026-08-24T05:22:13.607018+00:00",{"items":135,"total":20},[],{"items":137,"total":20},[],{"items":139,"total":20},[]]