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device）との実質的同等性を示すことで市販が認められる仕組みであり、クラスIIIの機器に適用されるPMA（市販前承認）と比べて相対的に簡易な審査プロセスとなっています。","claude-sonnet-5","754c1b8f78753ff352f1b1c56df6667c6d604e7dee16d3f439b2b1bd8b9cda8c","2026-08-24T02:37:21.239845+00:00",{"product_code":6,"summary_ja":143,"stats":144,"stats_hash":160,"model_name":139,"created_at":161,"updated_at":161},"本製品コードの510(k)累計件数は9件で、5社が参入していますが、直近5年間の届出はなく、最新の判定は2020年4月となっています。不具合報告は累計約30件で、内訳は傷害が32件、死亡が1件、不具合（Malfunction）が1件となっており、傷害の報告が大半を占めています。主な問題としては、Unexpected Therapeutic Results（予期しない治療結果）、Output Problem（出力の問題）、Patient-Device Incompatibility（患者と機器の不適合）が挙げられており、直近の報告は2025年5月時点まで確認されています。回収については累計0件で、これまでのところ確認されていません。",{"pma":145,"k510":146,"as_of":149,"events":150,"recalls":154,"top_problems":156},{"latest":37,"originals":36,"supplements":36},{"total":38,"last5y":36,"latest":147,"applicants":148},"2020-04-26",5,"2026-08",{"death":151,"other":36,"total":39,"injury":152,"last5y":39,"malfunction":151,"latest_month":153},1,32,"2025-05",{"total":36,"last5y":36,"latest":37,"class_i":36,"class_ii":36,"class_iii":36,"top_root_causes":155},[],[157,158,159],"Unexpected Therapeutic Results","Output Problem","Patient-Device Incompatibility","32189db9b6b75f2c4a123ed0e04d37e8fd2011ad39ffa5d4327dbd004abecdda","2026-08-24T05:16:12.270965+00:00",{"items":163,"total":36},[],{"items":165,"total":38},[166,172,178,181,185,189,192,196,199],{"k_number":26,"device_name":167,"applicant":168,"decision_date":147,"clearance_type":169,"decision_code":170,"statement_or_summary":171},"MECTA Sigma","Mecta 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