[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-MZK":3},{"classification":4,"mappedDevices":23,"similarCandidates":24,"relatedClassifications":98,"syncDates":99,"translation":106,"marketSummary":112,"recalls":127,"k510s":129,"pmas":131},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":9,"implant_flag":13,"life_sustain_support_flag":13,"gmp_exempt_flag":13,"raw":14,"created_at":18,"updated_at":19,"recall_count":20,"latest_recall_date":21,"k510_count":20,"pma_count":20,"event_count":22},1576,"MZK","System, Separation, Hematopoietic Stem Cell","3","","Unknown","HE","2",false,{"openfda":15,"definition":9,"device_name":7,"review_code":9,"device_class":8,"implant_flag":16,"product_code":6,"review_panel":11,"gmp_exempt_flag":16,"third_party_flag":16,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":16,"medical_specialty_description":10,"summary_malfunction_reporting":17},{},"N","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-24T02:00:47.808424+00:00",0,null,27,[],[25,33,41,48,55,62,69,77,84,91],{"medical_device_id":26,"generic_name":27,"class_classification":28,"jmdn_code":29,"name_similarity":30,"definition_similarity":20,"vector_similarity":31,"score":32},3564,"血球分離装置","Ⅰ","15113000",0.276596,0.776604,0.0320184,{"medical_device_id":34,"generic_name":35,"class_classification":36,"jmdn_code":37,"name_similarity":38,"definition_similarity":20,"vector_similarity":39,"score":40},753,"血液濾過用装置","Ⅲ","35453000",0.340909,0.719277,0.0317781,{"medical_device_id":42,"generic_name":43,"class_classification":28,"jmdn_code":44,"name_similarity":45,"definition_similarity":20,"vector_similarity":46,"score":47},3565,"細胞・血漿用血液分離装置","16901000",0.280702,0.738916,0.031746,{"medical_device_id":49,"generic_name":50,"class_classification":36,"jmdn_code":51,"name_similarity":52,"definition_similarity":20,"vector_similarity":53,"score":54},761,"持続緩徐式血液濾過用装置","70541000",0.275862,0.68002,0.0290832,{"medical_device_id":56,"generic_name":57,"class_classification":36,"jmdn_code":58,"name_similarity":59,"definition_similarity":20,"vector_similarity":60,"score":61},1082,"血液成分分離キット","58331003",0.214286,0.745401,0.0287873,{"medical_device_id":63,"generic_name":64,"class_classification":36,"jmdn_code":65,"name_similarity":66,"definition_similarity":20,"vector_similarity":67,"score":68},708,"血液透析濾過用装置","70520000",0.319149,0.66498,0.028629,{"medical_device_id":70,"generic_name":71,"class_classification":72,"jmdn_code":73,"name_similarity":74,"definition_similarity":20,"vector_similarity":75,"score":76},2991,"血液成分分離用装置","Ⅱ","58329002",0.20339,0.72547,0.0273897,{"medical_device_id":78,"generic_name":79,"class_classification":36,"jmdn_code":80,"name_similarity":81,"definition_similarity":20,"vector_similarity":82,"score":83},756,"膜型血漿分離用装置","36426000",0.22449,0.672641,0.0272424,{"medical_device_id":85,"generic_name":86,"class_classification":28,"jmdn_code":87,"name_similarity":88,"definition_similarity":20,"vector_similarity":89,"score":90},3878,"手術台システム","37325000",0.25,0.6526,0.025817,{"medical_device_id":92,"generic_name":93,"class_classification":72,"jmdn_code":94,"name_similarity":95,"definition_similarity":20,"vector_similarity":96,"score":97},2357,"心臓保存・搬送装置","37276000",0.220339,0.662476,0.0255617,[],{"510k":100,"classification":101,"enforcement":102,"event":103,"pma":104,"warning_letter":105},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":107,"definition_ja":21,"commentary_ja":108,"model_name":109,"source_hash":110,"reviewed_by":21,"reviewed_at":21,"created_at":111,"updated_at":111},"造血幹細胞分離システム","この機器は米国においてクラスIIIに分類されており、原則として市販前承認（PMA）による審査を経て市販が認められます。クラスIIIは人体への潜在的リスクが最も高い区分であり、有効性および安全性を示す科学的データに基づく厳格な審査が求められます。","claude-sonnet-5","3eede66de77da7c21930ba25e47e5f2398ecb7d2fc67caa54a48e14563d862c2","2026-08-24T02:15:50.744711+00:00",{"product_code":6,"summary_ja":113,"stats":114,"stats_hash":125,"model_name":109,"created_at":126,"updated_at":126},"本製品コードでは、510(k)およびPMAによる承認・届出の実績は確認されていません。不具合報告（MDR）は累計約30件で、その大半が不具合（Malfunction）に関するもので、傷害報告が1件、死亡報告は0件となっています。直近5年間の報告はなく、最新の報告は2010年4月です。回収については、これまでに実施された事例は確認されていません。",{"pma":115,"k510":116,"as_of":117,"events":118,"recalls":122,"top_problems":124},{"latest":21,"originals":20,"supplements":20},{"total":20,"last5y":20,"latest":21,"applicants":20},"2026-08",{"death":20,"other":20,"total":22,"injury":119,"last5y":20,"malfunction":120,"latest_month":121},1,26,"2010-04",{"total":20,"last5y":20,"latest":21,"class_i":20,"class_ii":20,"class_iii":20,"top_root_causes":123},[],[],"24093c181ae9a127132a1b5b16d19a5ea4ba414c1b70887de54811c22adceba0","2026-08-24T04:57:04.90455+00:00",{"items":128,"total":20},[],{"items":130,"total":20},[],{"items":132,"total":20},[]]