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Exempt）の対象とされており、市販前届出を行うことなく市場に出すことが可能です。これはクラスIIの中でもリスクが比較的低く、既存の性能基準等により安全性・有効性が確保できると判断された品目に適用される取扱いです。","claude-sonnet-5","2cf01c0eb8688225e00690356466fb5e2f170e7bf85a341b09c47dfd6b449a26","2026-08-24T02:30:13.381035+00:00",{"product_code":6,"summary_ja":147,"stats":148,"stats_hash":164,"model_name":143,"created_at":165,"updated_at":165},"本製品コードは届出免除の対象であり、510(k)は累計2件で直近5年の届出は確認されていません。不具合報告は累計約40件で、内訳は不具合（Malfunction）が約20件、傷害が約10件、死亡報告は確認されていません。主な問題としてはApplication Program Problem（アプリケーションプログラムの問題）、Computer Software Problem（コンピュータソフトウェアの問題）、Wireless Communication 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