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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区分であり、クラスIII機器に適用される市販前承認（PMA）と比べて相対的にリスクが低い機器に用いられる審査プロセスです。","claude-sonnet-5","bb2352e998058e24aaea82ea698de7813add86f408c2c2c5c81b534bf4fde461","2026-08-24T03:37:43.881155+00:00",{"product_code":6,"summary_ja":133,"stats":134,"stats_hash":147,"model_name":129,"created_at":148,"updated_at":148},"510(k)の累計件数は2件で、参入企業数は2社、直近5年間でも2件の届出が確認されており、最新の判定は2026年4月です。不具合報告は累計約30件で、その大半がMalfunction（不具合）であり、死亡・傷害の報告は確認されていません。主な問題としてはComputer Software Problem（コンピュータソフトウェアの問題）、Application Program Version or Upgrade Problem（アプリケーションプログラムのバージョン・更新の問題）、Date\u002FTime-Related Software 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