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device）との実質的同等性を示すことにより市販が認められる審査区分であり、クラスIIIに適用される市販前承認（PMA）に比べて相対的にリスクが低い機器に用いられる仕組みです。","claude-sonnet-5","95462ad5e06a6d67e3cdcf3f2fc7e0e6a2bd39d3044de7aca5b1702ce883be71","2026-08-24T03:33:38.802601+00:00",{"product_code":6,"summary_ja":140,"stats":141,"stats_hash":153,"model_name":136,"created_at":154,"updated_at":154},"本製品はクラス II・510(k)（市販前届出）の区分で、累計届出件数は2件、直近5年でも2件、参入企業数は1社となっています。PMA（市販前承認）の実績は確認されていません。不具合報告（MDR）は累計3件で、傷害2件、不具合（Malfunction）1件、死亡報告は0件となっており、主な問題としてData Problem（データの問題）が挙げられています。回収については累計0件で、クラスI〜IIIいずれも確認されていません。",{"pma":142,"k510":143,"as_of":146,"events":147,"recalls":149,"top_problems":151},{"latest":38,"originals":37,"supplements":37},{"total":39,"last5y":39,"latest":144,"applicants":145},"2023-09-18",1,"2026-08",{"death":37,"other":37,"total":40,"injury":39,"last5y":40,"malfunction":145,"latest_month":148},"2026-06",{"total":37,"last5y":37,"latest":38,"class_i":37,"class_ii":37,"class_iii":37,"top_root_causes":150},[],[152],"Data 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