[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NSD":3},{"classification":4,"mappedDevices":31,"similarCandidates":32,"relatedClassifications":111,"syncDates":112,"translation":119,"marketSummary":126,"recalls":142,"k510s":144,"pmas":146},{"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":25,"updated_at":26,"recall_count":27,"latest_recall_date":28,"k510_count":27,"pma_count":29,"event_count":30},2815,"NSD","Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence","3","","Unknown","PA","2","In vitro diagnostic test to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via fluorescence in situ hybridization (fish) in urine specimens from persons suspected of having bladder cancer.  It is an adjunctive test for initial diagnosis of transitional cell carcinoma in symptomatic patients and subsequently monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":23,"product_code":6,"review_panel":11,"gmp_exempt_flag":23,"third_party_flag":23,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":23,"medical_specialty_description":10,"summary_malfunction_reporting":24},{"fei_number":17,"pma_number":20,"registration_number":22},[18,19],"3005248192","3019837962",[21],"P030052",[18,19],"N","Ineligible","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:47.513022+00:00",0,null,24,6,[],[33,42,51,59,66,74,81,89,96,104],{"medical_device_id":34,"generic_name":35,"class_classification":36,"jmdn_code":37,"name_similarity":38,"definition_similarity":39,"vector_similarity":40,"score":41},1301,"膀胱用超音波画像診断装置","Ⅱ","70013000",0.153153,0.220957,0.662973,0.0297268,{"medical_device_id":43,"generic_name":44,"class_classification":45,"jmdn_code":46,"name_similarity":47,"definition_similarity":48,"vector_similarity":49,"score":50},1089,"自己検査用血液凝固分析器","Ⅲ","56687003",0.234234,0.196133,0.515853,0.0163934,{"medical_device_id":52,"generic_name":53,"class_classification":45,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},1006,"医薬品含有歯科充填用コンポジットレジン","70847003",0.19685,0.173575,0.483488,0.016129,{"medical_device_id":60,"generic_name":61,"class_classification":45,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":58},1157,"遺伝子変異解析システム（がんゲノムプロファイリング検査用）","60943033",0.124031,0.194444,0.660886,{"medical_device_id":67,"generic_name":68,"class_classification":45,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":73},1140,"体細胞遺伝子変異解析システム（抗悪性腫瘍薬適応判定用）","71059003",0.0797546,0.206731,0.653393,0.015873,{"medical_device_id":75,"generic_name":76,"class_classification":36,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":73},2782,"歯科間接修復用コンポジットレジンキット","70864002",0.188034,0.172702,0.46286,{"medical_device_id":82,"generic_name":83,"class_classification":45,"jmdn_code":84,"name_similarity":85,"definition_similarity":86,"vector_similarity":87,"score":88},1020,"医薬品含有歯科間接修復用コンポジットレジン","70855003",0.184,0.193384,0.471795,0.015625,{"medical_device_id":90,"generic_name":91,"class_classification":36,"jmdn_code":92,"name_similarity":93,"definition_similarity":94,"vector_similarity":95,"score":88},1319,"膀胱向け超音波診断用プローブ","70019000",0.0849057,0.197125,0.650925,{"medical_device_id":97,"generic_name":98,"class_classification":45,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":103},1147,"遺伝子変異解析セット（がんゲノムプロファイリング検査用）","60943013",0.126984,0.164835,0.649305,0.0153846,{"medical_device_id":105,"generic_name":106,"class_classification":36,"jmdn_code":107,"name_similarity":108,"definition_similarity":109,"vector_similarity":110,"score":103},2398,"血液回路用モニタリングセット","70559000",0.188119,0.150888,0.508471,[],{"510k":113,"classification":114,"enforcement":115,"event":116,"pma":117,"warning_letter":118},"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":120,"definition_ja":121,"commentary_ja":122,"model_name":123,"source_hash":124,"reviewed_by":28,"reviewed_at":28,"created_at":125,"updated_at":125},"膀胱癌検出・再発モニタリング用蛍光in situハイブリダイゼーション（FISH）検査試薬","膀胱癌が疑われる者の尿検体において、蛍光in situハイブリダイゼーション（FISH）法により3番、7番、17番染色体の異数性および9p21遺伝子座の欠失を検出するための体外診断用検査である。これは、症状を有する患者における移行上皮癌の初期診断のための補助検査であり、かつ、既に膀胱癌と診断された患者における腫瘍再発の経過観察のための検査である。","本品は米国においてクラスIIIに分類されており、市販前承認（PMA）による審査の対象となっています。クラスIIIはFDAの分類の中で最も規制が厳しい区分であり、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、または安全性・有効性を確認するための情報が不十分な機器に適用されます。510(k)による市販前届出とは異なり、PMAでは臨床データを含む科学的根拠に基づく厳格な審査が求められます。","claude-sonnet-5","093629e1dcdd4b6461a917d57b86649040222ef2e06334564eeb4f89a89c2ffd","2026-08-24T02:18:13.311568+00:00",{"product_code":6,"summary_ja":127,"stats":128,"stats_hash":140,"model_name":123,"created_at":141,"updated_at":141},"本製品はPMA（市販前承認）区分の機器で、本承認の件数は確認されていませんが、一部変更承認は約20件が届出されており、直近の判定は2022年3月となっています。不具合報告は累計約6件で、大半が不具合（Malfunction）に関するものであり、死亡・傷害の報告は確認されていません。最新の報告は2020年2月で、直近5年間の報告は確認されていません。回収については累計件数がなく、クラスI〜IIIのいずれの回収も確認されていません。",{"pma":129,"k510":131,"as_of":132,"events":133,"recalls":137,"top_problems":139},{"latest":130,"originals":27,"supplements":29},"2022-03-18",{"total":27,"last5y":27,"latest":28,"applicants":27},"2026-08",{"death":27,"other":134,"total":30,"injury":27,"last5y":27,"malfunction":135,"latest_month":136},1,5,"2020-02",{"total":27,"last5y":27,"latest":28,"class_i":27,"class_ii":27,"class_iii":27,"top_root_causes":138},[],[],"aa87dbc87e57e83f97626ff9e81d8c10b495a56ddad8ae35870c83a45c527541","2026-08-24T04:59:09.208125+00:00",{"items":143,"total":27},[],{"items":145,"total":27},[],{"items":147,"total":29},[148,152,155,158,161,164,168,172,176,180,183,186,189,192,195,198,202,206,209,212],{"pma_number":21,"supplement_number":149,"trade_name":150,"applicant":151,"decision_date":130},"S028","UroVysion Bladder Cancer Kit","Abbott Molecular",{"pma_number":21,"supplement_number":153,"trade_name":150,"applicant":151,"decision_date":154},"S027","2020-12-11",{"pma_number":21,"supplement_number":156,"trade_name":150,"applicant":151,"decision_date":157},"S025","2019-05-08",{"pma_number":21,"supplement_number":159,"trade_name":150,"applicant":151,"decision_date":160},"S024","2018-08-29",{"pma_number":21,"supplement_number":162,"trade_name":150,"applicant":151,"decision_date":163},"S022","2018-03-12",{"pma_number":21,"supplement_number":165,"trade_name":166,"applicant":151,"decision_date":167},"S020","Urovysion Bladder Cancer Kit","2017-04-12",{"pma_number":21,"supplement_number":169,"trade_name":170,"applicant":151,"decision_date":171},"S019","URO VYSION BLADDER CANCER KIT","2016-10-11",{"pma_number":21,"supplement_number":173,"trade_name":174,"applicant":151,"decision_date":175},"S017","UROVYSION BLADDER CANCER KIT,PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT","2015-12-29",{"pma_number":21,"supplement_number":177,"trade_name":178,"applicant":151,"decision_date":179},"S016","UROVYSION BLADDER CANCER KIT","2014-08-14",{"pma_number":21,"supplement_number":181,"trade_name":170,"applicant":151,"decision_date":182},"S015","2014-07-16",{"pma_number":21,"supplement_number":184,"trade_name":178,"applicant":151,"decision_date":185},"S012","2014-01-24",{"pma_number":21,"supplement_number":187,"trade_name":178,"applicant":151,"decision_date":188},"S014","2013-12-20",{"pma_number":21,"supplement_number":190,"trade_name":170,"applicant":151,"decision_date":191},"S013","2013-11-27",{"pma_number":21,"supplement_number":193,"trade_name":178,"applicant":151,"decision_date":194},"S011","2013-02-10",{"pma_number":21,"supplement_number":196,"trade_name":178,"applicant":151,"decision_date":197},"S010","2012-11-13",{"pma_number":21,"supplement_number":199,"trade_name":200,"applicant":151,"decision_date":201},"S009","UROVYSION BLADDER CANCER KIT ASSAY","2012-08-10",{"pma_number":21,"supplement_number":203,"trade_name":204,"applicant":151,"decision_date":205},"S008","URO VYSION BLADDER CANCER KIT ASSAY","2011-07-20",{"pma_number":21,"supplement_number":207,"trade_name":200,"applicant":151,"decision_date":208},"S007","2011-06-01",{"pma_number":21,"supplement_number":210,"trade_name":178,"applicant":151,"decision_date":211},"S006","2011-05-26",{"pma_number":21,"supplement_number":213,"trade_name":178,"applicant":151,"decision_date":214},"S005","2011-04-08"]