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Exempt区分に該当します。これは、クラスIIに属する医療機器の中でも相対的にリスクが低く、一般管理および特別管理のみで安全性・有効性が確保できると判断される場合に適用される取り扱いです。したがって、市場に出す前に個別の届出審査を経る必要はありませんが、該当する特別管理要件を満たすことが求められます。","claude-sonnet-5","23a4f467fbe85a66944cbf85c6c0b58f0961cae072919df0876f1c9736403fe9","2026-08-24T02:30:13.381035+00:00",{"product_code":6,"summary_ja":139,"stats":140,"stats_hash":154,"model_name":135,"created_at":155,"updated_at":155},"本製品コードは届出免除（510(k) Exempt）であり、510(k)およびPMAの届出・承認実績は確認されていません。不具合報告は累計約38,000件と多数に上り、その大半が不具合（Malfunction）によるもので、死亡報告は0件、傷害報告は約40件です。主な問題としてはWireless Communication Problem（無線通信の問題）、Computer Software Problem（コンピュータソフトウェアの問題）、Communication or Transmission 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