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866.3820のもとでクラスIIに分類されており、市販に際しては市販前届出（510(k)）による審査区分が適用され、有効性及び安全性に関する基本的な性能が確認されます。","claude-sonnet-5","1d71c683e2df3b9f4d9335eb55fd134d4bb31e1c60a69b70a54bc1d68a832482","2026-08-24T01:53:33.449047+00:00",{"product_code":6,"summary_ja":173,"stats":174,"stats_hash":191,"model_name":169,"created_at":192,"updated_at":192},"本製品コードでは、510(k)の累計届出件数は約30件で、申請企業は26社にのぼりますが、直近5年間の届出は1件にとどまり、最新の判定は2025年10月となっています。不具合報告（MDR）は累計約40件で、その大半は不具合（Malfunction）によるものであり、死亡報告は0件、傷害は2件確認されています。主な問題としては、不正確・不適切・不正確な結果（Incorrect, Inadequate or Imprecise Result or Readings）、偽陰性結果（False Negative Result）、偽陽性結果（False Positive Result）が挙げられています。回収（リコール）については、累計件数が0件であり、該当する事例は確認されていません。",{"pma":175,"k510":176,"as_of":180,"events":181,"recalls":185,"top_problems":187},{"latest":80,"originals":79,"supplements":79},{"total":81,"last5y":177,"latest":178,"applicants":179},1,"2025-10-10",26,"2026-08",{"death":79,"other":177,"total":82,"injury":182,"last5y":183,"malfunction":81,"latest_month":184},2,23,"2024-07",{"total":79,"last5y":79,"latest":80,"class_i":79,"class_ii":79,"class_iii":79,"top_root_causes":186},[],[188,189,190],"Incorrect, Inadequate or Imprecise Result or Readings","False Negative Result","False Positive Result","02e6d5706d64973c5a2100beadde35b8fadf28035118fe49891d5dd17017d690","2026-08-24T04:26:51.412735+00:00",{"items":194,"total":79},[],{"items":196,"total":81},[197,203,207,210,213,217,222,226,230,234,238,242,246,250,254,258,262,264,268,272],{"k_number":19,"device_name":198,"applicant":199,"decision_date":178,"clearance_type":200,"decision_code":201,"statement_or_summary":202},"Gold Standard 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