[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QBA":3},{"classification":4,"mappedDevices":34,"similarCandidates":35,"relatedClassifications":118,"syncDates":119,"translation":126,"marketSummary":133,"recalls":149,"k510s":151,"pmas":153},{"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":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":28,"updated_at":29,"recall_count":30,"latest_recall_date":31,"k510_count":30,"pma_count":32,"event_count":33},5837,"QBA","Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation","3","","Unknown","GU","2","To preserve donor lungs prior to transplantation",false,{"openfda":16,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":26,"product_code":6,"review_panel":11,"gmp_exempt_flag":26,"third_party_flag":26,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":26,"medical_specialty_description":10,"summary_malfunction_reporting":27},{"fei_number":17,"pma_number":23,"registration_number":25},[18,19,20,21,22],"3003152463","2518435","3003708554","1047843","1220477",[24],"P160013",[18,19,20,21,22],"N","Ineligible","2026-08-18T05:52:52.949882+00:00","2026-08-24T02:00:48.095002+00:00",0,null,19,2,[],[36,45,53,61,69,78,86,95,102,110],{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":42,"vector_similarity":43,"score":44},2357,"心臓保存・搬送装置","Ⅱ","37276000",0.236364,0.149254,0.705546,0.031746,{"medical_device_id":46,"generic_name":47,"class_classification":39,"jmdn_code":48,"name_similarity":49,"definition_similarity":50,"vector_similarity":51,"score":52},2397,"人工心肺用プライミング溶液フィルタ","36080000",0.170543,0.130841,0.706845,0.0312805,{"medical_device_id":54,"generic_name":55,"class_classification":39,"jmdn_code":56,"name_similarity":57,"definition_similarity":58,"vector_similarity":59,"score":60},2359,"肝臓保存・搬送装置","42919000",0.245455,0.154229,0.696094,0.0308349,{"medical_device_id":62,"generic_name":63,"class_classification":39,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":68},2358,"腎臓保存・搬送装置","33479000",0.232143,0.147783,0.678258,0.0299107,{"medical_device_id":70,"generic_name":71,"class_classification":72,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":77},763,"腹水濾過濃縮用装置","Ⅲ","70543000",0.14876,0.0614525,0.674855,0.0255168,{"medical_device_id":79,"generic_name":80,"class_classification":72,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":85},1103,"気管支サーモプラスティ用カテーテルシステム","44775003",0.172131,0.0274725,0.640465,0.0253968,{"medical_device_id":87,"generic_name":88,"class_classification":89,"jmdn_code":90,"name_similarity":91,"definition_similarity":92,"vector_similarity":93,"score":94},1182,"心臓用補綴材留置用デリバリーシステム","Ⅳ","45419004",0.267176,0.0837989,0.582489,0.0163934,{"medical_device_id":96,"generic_name":97,"class_classification":39,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":94},2375,"人工心肺用熱交換器","11973112",0.0629921,0.0657895,0.737447,{"medical_device_id":103,"generic_name":104,"class_classification":72,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":109},715,"ヘパリン使用人工心肺用熱交換器","11973213",0.0362319,0.0621762,0.70538,0.015625,{"medical_device_id":111,"generic_name":112,"class_classification":89,"jmdn_code":113,"name_similarity":114,"definition_similarity":115,"vector_similarity":116,"score":117},1084,"中心循環系非吸収性局所止血材","31744024",0.2,0.0777778,0.571006,0.0153846,[],{"510k":120,"classification":121,"enforcement":122,"event":123,"pma":124,"warning_letter":125},"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":127,"definition_ja":128,"commentary_ja":129,"model_name":130,"source_hash":131,"reviewed_by":31,"reviewed_at":31,"created_at":132,"updated_at":132},"標準基準ドナー肺移植前保存用常温機械灌流システム","移植前にドナー肺を保存するためのものである。","この機器はクラスIIIに分類されており、米国では市販前承認（PMA）による審査が必要です。クラスIIIは人の生命維持や健康に重大な影響を及ぼす可能性がある機器に適用される最も規制の厳しい区分であり、有効性と安全性を示す十分な科学的証拠の提出が求められます。","claude-sonnet-5","679e15ec99504c025838fa59faab896984447a7baa636a7695793fcc670aef4e","2026-08-24T02:35:22.423427+00:00",{"product_code":6,"summary_ja":134,"stats":135,"stats_hash":147,"model_name":130,"created_at":148,"updated_at":148},"本製品はPMA（市販前承認）による審査区分で、本承認1件に加え一部変更承認が約20件（18件）行われており、直近では2026年5月に判定が出ています。不具合報告は累計2件と少数で、その内訳は傷害1件、不具合（Malfunction）1件となっており、死亡報告は0件です。直近5年間の報告件数も2件で、最新の報告は2026年5月です。回収については累計0件で、クラスI・II・IIIいずれも確認されていません。",{"pma":136,"k510":140,"as_of":141,"events":142,"recalls":144,"top_problems":146},{"latest":137,"originals":138,"supplements":139},"2026-05-13",1,18,{"total":30,"last5y":30,"latest":31,"applicants":30},"2026-08",{"death":30,"other":30,"total":33,"injury":138,"last5y":33,"malfunction":138,"latest_month":143},"2026-05",{"total":30,"last5y":30,"latest":31,"class_i":30,"class_ii":30,"class_iii":30,"top_root_causes":145},[],[],"fdb4bf63819bd736e075876889a80e8d0eed8a865e52896473c3ae4ea87a7bfd","2026-08-24T05:15:00.389328+00:00",{"items":150,"total":30},[],{"items":152,"total":30},[],{"items":154,"total":32},[155,159,163,166,170,173,176,178,181,184,188,192,195,199,202,204,207,210,213],{"pma_number":24,"supplement_number":156,"trade_name":157,"applicant":158,"decision_date":137},"S021","Organ Care System (OCS™) Lung System","TransMedics, Inc.",{"pma_number":24,"supplement_number":160,"trade_name":161,"applicant":158,"decision_date":162},"S020","Organ Care System™ (OCS™) Lung System","2025-12-16",{"pma_number":24,"supplement_number":164,"trade_name":161,"applicant":158,"decision_date":165},"S019","2025-10-22",{"pma_number":24,"supplement_number":167,"trade_name":168,"applicant":158,"decision_date":169},"S018","Organ Care System™ (OCS™) Lung","2024-10-11",{"pma_number":24,"supplement_number":171,"trade_name":157,"applicant":158,"decision_date":172},"S016","2024-01-09",{"pma_number":24,"supplement_number":174,"trade_name":168,"applicant":158,"decision_date":175},"S014","2023-06-28",{"pma_number":24,"supplement_number":177,"trade_name":157,"applicant":158,"decision_date":175},"S013",{"pma_number":24,"supplement_number":179,"trade_name":157,"applicant":158,"decision_date":180},"S012","2023-05-09",{"pma_number":24,"supplement_number":182,"trade_name":157,"applicant":158,"decision_date":183},"S010","2023-02-24",{"pma_number":24,"supplement_number":185,"trade_name":186,"applicant":158,"decision_date":187},"S011","Organ Care System (OCS™) Lung","2023-02-23",{"pma_number":24,"supplement_number":189,"trade_name":190,"applicant":158,"decision_date":191},"S009","Organ Care System™ (OCS) Lung System","2022-05-06",{"pma_number":24,"supplement_number":193,"trade_name":157,"applicant":158,"decision_date":194},"S008","2021-08-02",{"pma_number":24,"supplement_number":196,"trade_name":197,"applicant":158,"decision_date":198},"S007","Organ Care System (OCS) Lung System","2020-12-03",{"pma_number":24,"supplement_number":200,"trade_name":197,"applicant":158,"decision_date":201},"S006","2019-12-20",{"pma_number":24,"supplement_number":203,"trade_name":197,"applicant":158,"decision_date":201},"S005",{"pma_number":24,"supplement_number":205,"trade_name":157,"applicant":158,"decision_date":206},"S002","2019-05-31",{"pma_number":24,"supplement_number":208,"trade_name":157,"applicant":158,"decision_date":209},"S003","2018-12-21",{"pma_number":24,"supplement_number":211,"trade_name":157,"applicant":158,"decision_date":212},"S001","2018-06-14",{"pma_number":24,"supplement_number":9,"trade_name":157,"applicant":158,"decision_date":214},"2018-03-22"]