[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-RDN":3},{"classification":4,"mappedDevices":22,"similarCandidates":23,"relatedClassifications":98,"syncDates":99,"translation":106,"marketSummary":113,"recalls":126,"k510s":128,"pmas":130},{"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},2647,"RDN","Walkie-Talkie","N","","Unknown","A machine that utilizes microwave radiation for communication as in walkie talkies.",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","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:49.169481+00:00",0,2,[],[24,33,41,49,57,63,70,77,85,91],{"medical_device_id":25,"generic_name":26,"class_classification":27,"jmdn_code":28,"name_similarity":29,"definition_similarity":30,"vector_similarity":31,"score":32},2476,"超短波治療器","Ⅱ","11246000",0.0833333,0.116197,0.598014,0.023399,{"medical_device_id":34,"generic_name":35,"class_classification":36,"jmdn_code":37,"name_similarity":20,"definition_similarity":38,"vector_similarity":39,"score":40},947,"マイクロ波メス","Ⅲ","70650000",0.232704,0.636956,0.0163934,{"medical_device_id":42,"generic_name":43,"class_classification":44,"jmdn_code":45,"name_similarity":46,"definition_similarity":47,"vector_similarity":48,"score":40},4001,"歯科用ワックス形成器","Ⅰ","35794000",0.12,0.117318,0.464523,{"medical_device_id":50,"generic_name":51,"class_classification":27,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":56},2475,"マイクロ波治療器","11245000",0.0294118,0.149321,0.63229,0.016129,{"medical_device_id":58,"generic_name":59,"class_classification":44,"jmdn_code":60,"name_similarity":46,"definition_similarity":61,"vector_similarity":62,"score":56},4135,"歯科用ワックス成形品","31836020",0.113514,0.474021,{"medical_device_id":64,"generic_name":65,"class_classification":36,"jmdn_code":66,"name_similarity":20,"definition_similarity":67,"vector_similarity":68,"score":69},973,"マイクロ波ハイパサーミアシステム","40783000",0.111801,0.631788,0.015873,{"medical_device_id":71,"generic_name":72,"class_classification":44,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":69},4124,"歯科用キャスティングワックス","16189000",0.115385,0.143885,0.432914,{"medical_device_id":78,"generic_name":79,"class_classification":27,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},1441,"心電図電話伝送装置","70064000",0.0222222,0.163399,0.627257,0.015625,{"medical_device_id":86,"generic_name":87,"class_classification":44,"jmdn_code":88,"name_similarity":46,"definition_similarity":89,"vector_similarity":90,"score":84},4127,"歯科用ステッキワックス","70895000",0.112903,0.434454,{"medical_device_id":92,"generic_name":93,"class_classification":27,"jmdn_code":94,"name_similarity":20,"definition_similarity":95,"vector_similarity":96,"score":97},2571,"単回使用マイクロ波尿道前立腺肥大症用ハイパサーミア装置カテーテル","42455010",0.143443,0.621637,0.0153846,[],{"510k":100,"classification":101,"enforcement":102,"event":103,"pma":104,"warning_letter":105},"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":107,"definition_ja":108,"commentary_ja":109,"model_name":110,"source_hash":111,"reviewed_by":12,"reviewed_at":12,"created_at":112,"updated_at":112},"トランシーバー","トランシーバーのように通信のためにマイクロ波放射を利用する機械である。","この製品は、無線通信のためにマイクロ波を利用する装置であるトランシーバーを指します。米国の規制上は「分類対象外（Not classified）」とされており、クラスI・II・IIIのいずれの医療機器区分にも該当せず、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もなっていません。","claude-sonnet-5","b626456ce071ae6d89d4d2e3e204001d69b59e58fb8b6a69032d7ad5c1134802","2026-08-24T03:37:43.881155+00:00",{"product_code":6,"summary_ja":114,"stats":115,"stats_hash":124,"model_name":110,"created_at":125,"updated_at":125},"本製品コードについては、510(k)および PMA による市販前届出・承認の累計件数はいずれも確認されていません。不具合報告（MDR）は累計約2件で、死亡・傷害・不具合（Malfunction）の報告はなく、いずれも「その他」に分類される報告となっています。直近5年間の報告はなく、最新の報告は2020年9月となっています。回収（リコール）についても累計件数は確認されていません。",{"pma":116,"k510":117,"as_of":118,"events":119,"recalls":121,"top_problems":123},{"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":20,"malfunction":20,"latest_month":120},"2020-09",{"total":20,"last5y":20,"latest":12,"class_i":20,"class_ii":20,"class_iii":20,"top_root_causes":122},[],[],"e1c169ead029910d08adacedbfa16f8d7053e8f9035147131016051f5e6b9e45","2026-08-24T05:22:13.607018+00:00",{"items":127,"total":20},[],{"items":129,"total":20},[],{"items":131,"total":20},[]]