[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-IOA":3},{"classification":4,"mappedDevices":31,"similarCandidates":32,"relatedClassifications":104,"syncDates":109,"translation":116,"marketSummary":122,"recalls":136,"k510s":138,"pmas":158},{"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":25,"updated_at":26,"recall_count":27,"latest_recall_date":28,"k510_count":29,"pma_count":27,"event_count":30},1462,"IOA","Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat","2","890.5275","PM","Physical Medicine","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":22,"product_code":6,"review_panel":10,"gmp_exempt_flag":22,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":22,"medical_specialty_description":11,"summary_malfunction_reporting":24},{"k_number":17},[18,19,20,21],"K860082","K862029","K895000","K941567","N","Y","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:48.882786+00:00",0,null,4,1,[],[33,41,48,55,62,70,77,84,91,97],{"medical_device_id":34,"generic_name":35,"class_classification":36,"jmdn_code":37,"name_similarity":38,"definition_similarity":27,"vector_similarity":39,"score":40},2475,"マイクロ波治療器","Ⅱ","11245000",0.235294,0.821269,0.0322665,{"medical_device_id":42,"generic_name":43,"class_classification":36,"jmdn_code":44,"name_similarity":45,"definition_similarity":27,"vector_similarity":46,"score":47},2932,"家庭用短波ジアテルミー装置","34668000",0.243243,0.800188,0.0322581,{"medical_device_id":49,"generic_name":50,"class_classification":36,"jmdn_code":51,"name_similarity":52,"definition_similarity":27,"vector_similarity":53,"score":54},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",0.245283,0.757849,0.0320184,{"medical_device_id":56,"generic_name":57,"class_classification":36,"jmdn_code":58,"name_similarity":59,"definition_similarity":27,"vector_similarity":60,"score":61},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",0.201835,0.761495,0.0305789,{"medical_device_id":63,"generic_name":64,"class_classification":65,"jmdn_code":66,"name_similarity":67,"definition_similarity":27,"vector_similarity":68,"score":69},973,"マイクロ波ハイパサーミアシステム","Ⅲ","40783000",0.186667,0.757773,0.0287179,{"medical_device_id":71,"generic_name":72,"class_classification":36,"jmdn_code":73,"name_similarity":74,"definition_similarity":27,"vector_similarity":75,"score":76},2960,"家庭用温熱治療器","71017000",0.2,0.696315,0.0273133,{"medical_device_id":78,"generic_name":79,"class_classification":36,"jmdn_code":80,"name_similarity":81,"definition_similarity":27,"vector_similarity":82,"score":83},2933,"家庭用超短波治療器","70988000",0.181818,0.719442,0.0270715,{"medical_device_id":85,"generic_name":86,"class_classification":36,"jmdn_code":87,"name_similarity":88,"definition_similarity":27,"vector_similarity":89,"score":90},2348,"未包装品用マイクロ波滅菌器","37494000",0.204819,0.678061,0.0264196,{"medical_device_id":92,"generic_name":93,"class_classification":36,"jmdn_code":94,"name_similarity":67,"definition_similarity":27,"vector_similarity":95,"score":96},2350,"液体用マイクロ波滅菌器","37509000",0.687524,0.0255617,{"medical_device_id":98,"generic_name":99,"class_classification":36,"jmdn_code":100,"name_similarity":101,"definition_similarity":27,"vector_similarity":102,"score":103},2349,"包装品用マイクロ波滅菌器","37495000",0.195122,0.67636,0.0254481,[105],{"product_code":106,"device_name":107,"device_class":108,"k510_count":27},"HPH","Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat","3",{"510k":110,"classification":111,"enforcement":112,"event":113,"pma":114,"warning_letter":115},"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":117,"definition_ja":28,"commentary_ja":118,"model_name":119,"source_hash":120,"reviewed_by":28,"reviewed_at":28,"created_at":121,"updated_at":121},"マイクロ波ジアテルミー装置(温熱療法用)","この機器は、治療用に深部組織を温めるためにマイクロ波エネルギーを利用するジアテルミー装置です。米国ではクラスIIに分類されており、市販前届出（510(k)）による審査を経て市販されることになります。510(k)は、既存の同等な機器との実質的同等性を示すことで市販が認められる審査区分であり、クラスIIIの機器に求められる市販前承認（PMA）よりも簡略化された手続きです。","claude-sonnet-5","3379a0bb35b2eeb2801f1e643ce26d0d0a6a5f5b68353cebce80e93f9291f9e8","2026-08-24T01:59:49.679032+00:00",{"product_code":6,"summary_ja":123,"stats":124,"stats_hash":134,"model_name":119,"created_at":135,"updated_at":135},"510(k)の累計届出件数は4件、参入企業数は4社となっており、最新の判定は1996年4月で、直近5年間の届出は確認されていません。不具合報告は累計1件で、内容はMalfunction（不具合）によるもので、死亡・傷害の報告は確認されていません。回収については累計・直近5年ともに0件で、クラスIを含む回収事例は確認されていません。",{"pma":125,"k510":126,"as_of":128,"events":129,"recalls":131,"top_problems":133},{"latest":28,"originals":27,"supplements":27},{"total":29,"last5y":27,"latest":127,"applicants":29},"1996-04-22","2026-08",{"death":27,"other":27,"total":30,"injury":27,"last5y":27,"malfunction":30,"latest_month":130},"1993-12",{"total":27,"last5y":27,"latest":28,"class_i":27,"class_ii":27,"class_iii":27,"top_root_causes":132},[],[],"1e7beabf1c4751a9d76cdb366f38b8cb56e333e6b6164e970001a592c47eaf8c","2026-08-24T04:39:50.654259+00:00",{"items":137,"total":27},[],{"items":139,"total":29},[140,146,150,154],{"k_number":21,"device_name":141,"applicant":142,"decision_date":127,"clearance_type":143,"decision_code":144,"statement_or_summary":145},"DIATHERMY DEVICE-MICROFOCUS","Cheung Laboratories, Inc.","Traditional","SESE","Statement",{"k_number":20,"device_name":147,"applicant":148,"decision_date":149,"clearance_type":143,"decision_code":144,"statement_or_summary":28},"NEMECTRON MICROWAVE","Nemectron Medical, Inc.","1990-07-27",{"k_number":19,"device_name":151,"applicant":152,"decision_date":153,"clearance_type":143,"decision_code":144,"statement_or_summary":28},"SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT","Elmed, Inc.","1986-07-16",{"k_number":18,"device_name":155,"applicant":156,"decision_date":157,"clearance_type":143,"decision_code":144,"statement_or_summary":28},"THERMOTRON 918","Medical Microwave Research Corp.","1986-03-27",{"items":159,"total":27},[]]