[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LOC":3},{"classification":4,"mappedDevices":27,"similarCandidates":28,"relatedClassifications":100,"syncDates":101,"translation":108,"marketSummary":114,"recalls":130,"k510s":132,"pmas":134},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":9,"implant_flag":13,"life_sustain_support_flag":13,"gmp_exempt_flag":13,"raw":14,"created_at":21,"updated_at":22,"recall_count":23,"latest_recall_date":24,"k510_count":23,"pma_count":25,"event_count":26},4557,"LOC","System, Rf\u002FMicrowave Hyperthermia, Cancer Treatment","3","","Unknown","RA","2",false,{"openfda":15,"definition":9,"device_name":7,"review_code":9,"device_class":8,"implant_flag":19,"product_code":6,"review_panel":11,"gmp_exempt_flag":19,"third_party_flag":19,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":19,"medical_specialty_description":10,"summary_malfunction_reporting":20},{"pma_number":16},[17,18],"P840015","P820088","N","Eligible","2026-08-18T05:52:52.082407+00:00","2026-08-24T02:00:48.882786+00:00",0,null,27,1,[],[29,37,45,52,59,66,72,79,86,93],{"medical_device_id":30,"generic_name":31,"class_classification":32,"jmdn_code":33,"name_similarity":34,"definition_similarity":23,"vector_similarity":35,"score":36},973,"マイクロ波ハイパサーミアシステム","Ⅲ","40783000",0.6,0.851344,0.0327869,{"medical_device_id":38,"generic_name":39,"class_classification":40,"jmdn_code":41,"name_similarity":42,"definition_similarity":23,"vector_similarity":43,"score":44},2475,"マイクロ波治療器","Ⅱ","11245000",0.363636,0.824647,0.031746,{"medical_device_id":46,"generic_name":47,"class_classification":32,"jmdn_code":48,"name_similarity":49,"definition_similarity":23,"vector_similarity":50,"score":51},977,"レーザハイパサーミアシステム","70672000",0.381818,0.796931,0.0315136,{"medical_device_id":53,"generic_name":54,"class_classification":32,"jmdn_code":55,"name_similarity":56,"definition_similarity":23,"vector_similarity":57,"score":58},974,"高周波式ハイパサーミアシステム","40782000",0.3125,0.827096,0.0308349,{"medical_device_id":60,"generic_name":61,"class_classification":32,"jmdn_code":62,"name_similarity":63,"definition_similarity":23,"vector_similarity":64,"score":65},978,"コンビネーション型ハイパサーミアシステム","40785000",0.344262,0.79766,0.0307765,{"medical_device_id":67,"generic_name":68,"class_classification":32,"jmdn_code":69,"name_similarity":63,"definition_similarity":23,"vector_similarity":70,"score":71},976,"液体加温ハイパサーミアシステム","40784000",0.754506,0.0296703,{"medical_device_id":73,"generic_name":74,"class_classification":32,"jmdn_code":75,"name_similarity":76,"definition_similarity":23,"vector_similarity":77,"score":78},975,"超音波式ハイパサーミアシステム","40781000",0.327869,0.768369,0.0296313,{"medical_device_id":80,"generic_name":81,"class_classification":40,"jmdn_code":82,"name_similarity":83,"definition_similarity":23,"vector_similarity":84,"score":85},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",0.28125,0.781697,0.0294372,{"medical_device_id":87,"generic_name":88,"class_classification":40,"jmdn_code":89,"name_similarity":90,"definition_similarity":23,"vector_similarity":91,"score":92},2570,"再使用可能な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","36921000",0.284211,0.77681,0.0294181,{"medical_device_id":94,"generic_name":95,"class_classification":40,"jmdn_code":96,"name_similarity":97,"definition_similarity":23,"vector_similarity":98,"score":99},1352,"マイクロ波サーモグラフィ装置","40802000",0.355932,0.708016,0.028612,[],{"510k":102,"classification":103,"enforcement":104,"event":105,"pma":106,"warning_letter":107},"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":109,"definition_ja":24,"commentary_ja":110,"model_name":111,"source_hash":112,"reviewed_by":24,"reviewed_at":24,"created_at":113,"updated_at":113},"がん治療用高周波\u002Fマイクロ波ハイパーサーミアシステム","これは、高周波またはマイクロ波エネルギーを用いてがん組織を加温し治療するためのシステムです。米国ではクラスIIIに分類されており、市販前承認（PMA）による審査を経て安全性及び有効性が確認される必要があります。","claude-sonnet-5","39a758fe3638750ddee8a3ad178393e1664339f61f1a769b0b0f3a8a8bb20819","2026-08-24T02:11:36.699753+00:00",{"product_code":6,"summary_ja":115,"stats":116,"stats_hash":128,"model_name":111,"created_at":129,"updated_at":129},"本製品はPMA（市販前承認）区分の機器であり、本承認が2件、一部変更承認が25件累計しており、最新の判定は2004年1月となっています。不具合報告（MDR）は累計1件で、死亡・傷害・不具合（Malfunction）の報告はいずれも確認されておらず、分類は「その他」となっています。回収については累計0件であり、クラスI・II・IIIのいずれも確認されていません。",{"pma":117,"k510":121,"as_of":122,"events":123,"recalls":125,"top_problems":127},{"latest":118,"originals":119,"supplements":120},"2004-01-20",2,25,{"total":23,"last5y":23,"latest":24,"applicants":23},"2026-08",{"death":23,"other":26,"total":26,"injury":23,"last5y":23,"malfunction":23,"latest_month":124},"2004-03",{"total":23,"last5y":23,"latest":24,"class_i":23,"class_ii":23,"class_iii":23,"top_root_causes":126},[],[],"c0243bffcf60ced26f15663741b90374eabb42edaa574da9ba8b3a32fe7a3538","2026-08-24T04:50:56.354429+00:00",{"items":131,"total":23},[],{"items":133,"total":23},[],{"items":135,"total":25},[136,140,143,147,150,154,157,161,164,167,169,172,174,176,179,181,184,186,189,192],{"pma_number":18,"supplement_number":137,"trade_name":138,"applicant":139,"decision_date":118},"S017","BSD-500 HYPERTHERMIA SYSTEM","Pyrexar Medical, Inc.",{"pma_number":18,"supplement_number":141,"trade_name":138,"applicant":139,"decision_date":142},"S016","2003-10-08",{"pma_number":18,"supplement_number":144,"trade_name":145,"applicant":139,"decision_date":146},"S014","BSD 1000 HYPERTHERMIA SYSTEM","1991-11-26",{"pma_number":18,"supplement_number":148,"trade_name":145,"applicant":139,"decision_date":149},"S008","1991-03-28",{"pma_number":17,"supplement_number":144,"trade_name":151,"applicant":152,"decision_date":153},"CLINI-THERM MARK I\u002FIV\u002F DIPOLE ARRAY APPLICATOR","Clini-Therm Corp.","1990-07-17",{"pma_number":18,"supplement_number":155,"trade_name":145,"applicant":139,"decision_date":156},"S011","1990-06-21",{"pma_number":17,"supplement_number":158,"trade_name":159,"applicant":152,"decision_date":160},"S013","CLINI-THERM MARK I\u002FIV","1988-12-15",{"pma_number":18,"supplement_number":162,"trade_name":145,"applicant":139,"decision_date":163},"S006","1988-12-13",{"pma_number":17,"supplement_number":165,"trade_name":159,"applicant":152,"decision_date":166},"S012","1988-08-22",{"pma_number":17,"supplement_number":155,"trade_name":159,"applicant":152,"decision_date":168},"1988-04-05",{"pma_number":17,"supplement_number":170,"trade_name":159,"applicant":152,"decision_date":171},"S010","1988-02-29",{"pma_number":17,"supplement_number":148,"trade_name":159,"applicant":152,"decision_date":173},"1988-02-19",{"pma_number":17,"supplement_number":162,"trade_name":159,"applicant":152,"decision_date":175},"1988-01-21",{"pma_number":17,"supplement_number":177,"trade_name":159,"applicant":152,"decision_date":178},"S009","1987-12-29",{"pma_number":17,"supplement_number":180,"trade_name":159,"applicant":152,"decision_date":178},"S007",{"pma_number":17,"supplement_number":182,"trade_name":159,"applicant":152,"decision_date":183},"S005","1987-12-18",{"pma_number":18,"supplement_number":182,"trade_name":145,"applicant":139,"decision_date":185},"1986-09-23",{"pma_number":17,"supplement_number":187,"trade_name":159,"applicant":152,"decision_date":188},"S004","1986-06-12",{"pma_number":17,"supplement_number":190,"trade_name":159,"applicant":152,"decision_date":191},"S003","1986-04-15",{"pma_number":17,"supplement_number":193,"trade_name":159,"applicant":152,"decision_date":194},"S002","1985-12-13"]