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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審査区分であり、クラスIII機器に求められる市販前承認（PMA）よりも簡略化された手続きです。","claude-sonnet-5","44600be349bf79001713a62e3879c64081bf0ba05e5ec030651a5f6dde58a353","2026-08-24T03:40:21.731962+00:00",{"product_code":6,"summary_ja":132,"stats":133,"stats_hash":142,"model_name":128,"created_at":143,"updated_at":143},"本製品区分では、510(k)の累計件数は1件で、参入企業数は1社、直近5年の件数も1件となっており、2025年9月に判定が行われています。PMAの承認実績は確認されていません。不具合報告および回収については、いずれも件数が確認されていません。",{"pma":134,"k510":135,"as_of":137,"events":138,"recalls":139,"top_problems":141},{"latest":29,"originals":28,"supplements":28},{"total":30,"last5y":30,"latest":136,"applicants":30},"2025-09-23","2026-08",{"death":28,"other":28,"total":28,"injury":28,"last5y":28,"malfunction":28,"latest_month":29},{"total":28,"last5y":28,"latest":29,"class_i":28,"class_ii":28,"class_iii":28,"top_root_causes":140},[],[],"5a85548384e873c946bef27b94e054934663654653b38cb768a9601639dc5f61","2026-08-24T05:23:16.025025+00:00",{"items":145,"total":28},[],{"items":147,"total":30},[148],{"k_number":18,"device_name":149,"applicant":150,"decision_date":136,"clearance_type":151,"decision_code":152,"statement_or_summary":29},"Biolinq 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