[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HIX":3},{"classification":4,"mappedDevices":30,"similarCandidates":31,"relatedClassifications":104,"syncDates":105,"translation":112,"marketSummary":118,"recalls":131,"k510s":133,"pmas":144},{"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":27},1034,"HIX","Maxwell Spot, Ac-Powered","1","886.1435","OP","Ophthalmic","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":23,"product_code":6,"review_panel":10,"gmp_exempt_flag":23,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":23,"medical_specialty_description":11,"summary_malfunction_reporting":24},{"k_number":17,"fei_number":20,"registration_number":22},[18,19],"K831829","K801554",[21],"3009973336",[21],"N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:49.169481+00:00",0,null,2,[],[32,40,48,55,63,70,77,85,91,98],{"medical_device_id":33,"generic_name":34,"class_classification":35,"jmdn_code":36,"name_similarity":37,"definition_similarity":27,"vector_similarity":38,"score":39},2836,"電動式ケラトーム","Ⅱ","12222002",0.242424,0.597917,0.0308862,{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":27,"vector_similarity":46,"score":47},3868,"電動式ピンチバルブ","Ⅰ","70467000",0.228571,0.590021,0.028624,{"medical_device_id":49,"generic_name":50,"class_classification":35,"jmdn_code":51,"name_similarity":52,"definition_similarity":27,"vector_similarity":53,"score":54},2291,"電動式吸引用ポンプ","36616040",0.257143,0.584189,0.0281385,{"medical_device_id":56,"generic_name":57,"class_classification":58,"jmdn_code":59,"name_similarity":60,"definition_similarity":27,"vector_similarity":61,"score":62},944,"ライン電源式焼灼器","Ⅲ","35030000",0.222222,0.577419,0.0244813,{"medical_device_id":64,"generic_name":65,"class_classification":43,"jmdn_code":66,"name_similarity":67,"definition_similarity":27,"vector_similarity":68,"score":69},3335,"電動式胸部打診つち","35235000",0.205128,0.581523,0.0244484,{"medical_device_id":71,"generic_name":72,"class_classification":35,"jmdn_code":73,"name_similarity":74,"definition_similarity":27,"vector_similarity":75,"score":76},2603,"歯科用エアスケーラ","70704000",0.30303,0.557892,0.0163934,{"medical_device_id":78,"generic_name":79,"class_classification":80,"jmdn_code":81,"name_similarity":82,"definition_similarity":27,"vector_similarity":83,"score":84},53,"ヘパリン使用心臓用カテーテル型電極","Ⅳ","11434200",0.0307692,0.596789,0.016129,{"medical_device_id":86,"generic_name":87,"class_classification":43,"jmdn_code":88,"name_similarity":89,"definition_similarity":27,"vector_similarity":90,"score":84},4189,"ガス式解剖用のこぎり","44144000",0.263158,0.511509,{"medical_device_id":92,"generic_name":93,"class_classification":35,"jmdn_code":94,"name_similarity":95,"definition_similarity":27,"vector_similarity":96,"score":97},2885,"電動式手術用ドリルモータ","43915000",0.261905,0.521296,0.015873,{"medical_device_id":99,"generic_name":100,"class_classification":43,"jmdn_code":101,"name_similarity":102,"definition_similarity":27,"vector_similarity":103,"score":97},3413,"中心フリッカ値測定装置","70091000",0.0151515,0.594087,[],{"510k":106,"classification":107,"enforcement":108,"event":109,"pma":110,"warning_letter":111},"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":113,"definition_ja":28,"commentary_ja":114,"model_name":115,"source_hash":116,"reviewed_by":28,"reviewed_at":28,"created_at":117,"updated_at":117},"交流式マックスウェル視標投影装置","本品は米国FDAの分類において21 CFR 886.1435に規定される眼科用機器であり、交流電源で作動するマックスウェル視標投影装置です。デバイスクラスはクラスIに区分され、市販前届出（510(k)）が免除される品目として扱われています。これは、この種の機器が人体に対するリスクが低いと判断され、一般的な管理要件のみで安全性・有効性が確保できるとFDAが位置付けていることを意味します。","claude-sonnet-5","cf96da1ad6a884d6cd5a54ec9596a2588e8401c29fae38e93cb2b864b2e695c6","2026-08-24T01:56:53.662172+00:00",{"product_code":6,"summary_ja":119,"stats":120,"stats_hash":129,"model_name":115,"created_at":130,"updated_at":130},"本製品は届出免除（510(k) Exempt）区分であり、510(k)は累計2件、参入企業数は2社となっていますが、直近5年間の届出はありません。不具合報告については累計0件で、報告は確認されていません。回収についても累計0件であり、クラスI・II・IIIいずれも該当なく、回収実績は確認されていません。",{"pma":121,"k510":122,"as_of":124,"events":125,"recalls":126,"top_problems":128},{"latest":28,"originals":27,"supplements":27},{"total":29,"last5y":27,"latest":123,"applicants":29},"1983-10-19","2026-08",{"death":27,"other":27,"total":27,"injury":27,"last5y":27,"malfunction":27,"latest_month":28},{"total":27,"last5y":27,"latest":28,"class_i":27,"class_ii":27,"class_iii":27,"top_root_causes":127},[],[],"59e7ef58a83e49db292b68d00a4a03f08d058d3950c0a885d1161adf12aa16e8","2026-08-24T04:32:35.506862+00:00",{"items":132,"total":27},[],{"items":134,"total":29},[135,140],{"k_number":18,"device_name":136,"applicant":137,"decision_date":123,"clearance_type":138,"decision_code":139,"statement_or_summary":28},"KARICKHOFF FLYING CORPUSCLE VIEWER","Surgidev Corp.","Traditional","SESE",{"k_number":19,"device_name":141,"applicant":142,"decision_date":143,"clearance_type":138,"decision_code":139,"statement_or_summary":28},"STERILE CAST PADDING","Medi-Spec","1980-08-04",{"items":145,"total":27},[]]