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Hospital（一般病院用機器）分野に属します。クラスIは相対的にリスクが低い機器を対象とする区分であり、本品は510(k)（市販前届出）が免除される製品として扱われます。","claude-sonnet-5","16eac6e11b8168a08c11cab44abd240143d44106e4999def2709d0e3f07682cc","2026-08-24T01:51:19.839721+00:00",{"product_code":6,"summary_ja":145,"stats":146,"stats_hash":161,"model_name":141,"created_at":162,"updated_at":162},"本製品は届出免除（510(k) Exempt）に区分されており、510(k)およびPMAの承認・届出実績は確認されていません。不具合報告は累計約20件で、内訳は不具合（Malfunction）が約20件、傷害が約4件、死亡は0件となっており、直近5年間では約7件、最新の報告は2026年4月です。主な問題としては、汚染（Contamination）、機器の表示・ラベリングに関する問題（Device Markings\u002FLabelling Problem）、非医療従事者向け説明の不足（Inadequate Instructions for Non-Healthcare 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