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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、PMA（市販前承認）で要求されるような独立した臨床試験データの提出は原則として必要とされません。クラスIIは中程度のリスクを有する機器区分であり、性能基準や適合性確認などの特別管理を通じて安全性・有効性が確保される仕組みとなっています。","claude-sonnet-5","827aefc96ea555bf20993a4224067e2166cdde5e45dac32ffd8ed1288e1a49fa","2026-08-24T02:30:13.381035+00:00",{"product_code":6,"summary_ja":133,"stats":134,"stats_hash":143,"model_name":129,"created_at":144,"updated_at":144},"本製品コードでは、510(k)の累計届出件数は2件、参入企業数は2社となっており、最新の判定は2014年6月です。直近5年間の510(k)届出、PMA承認は確認されていません。不具合報告および回収についても、累計件数はいずれも0件で確認されていません。",{"pma":135,"k510":136,"as_of":138,"events":139,"recalls":140,"top_problems":142},{"latest":34,"originals":33,"supplements":33},{"total":35,"last5y":33,"latest":137,"applicants":35},"2014-06-27","2026-08",{"death":33,"other":33,"total":33,"injury":33,"last5y":33,"malfunction":33,"latest_month":34},{"total":33,"last5y":33,"latest":34,"class_i":33,"class_ii":33,"class_iii":33,"top_root_causes":141},[],[],"f306bc8e29736886bd8be3a9a24584f7bc3c45626b25d5edbd1b5199d6900d3d","2026-08-24T05:09:58.149854+00:00",{"items":146,"total":33},[],{"items":148,"total":35},[149,155],{"k_number":21,"device_name":150,"applicant":151,"decision_date":137,"clearance_type":152,"decision_code":153,"statement_or_summary":154},"EUROIMMUN 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