[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QUD":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":113,"syncDates":114,"translation":121,"marketSummary":128,"recalls":141,"k510s":143,"pmas":150},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":27,"updated_at":28,"recall_count":29,"latest_recall_date":30,"k510_count":31,"pma_count":29,"event_count":29},1864,"QUD","Blood Detection Capsule","2","876.1390","GU","Gastroenterology, Urology","1","Ingestible gastrointestinal blood detection capsule device is a prescription device that uses spectrophotometry (light absorption technology) to detect the presence or absence of blood in the gastrointestinal tract.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":20,"device_class":8,"implant_flag":25,"product_code":6,"review_panel":10,"gmp_exempt_flag":25,"third_party_flag":25,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":20,"life_sustain_support_flag":25,"medical_specialty_description":11,"summary_malfunction_reporting":26},{"k_number":17,"fei_number":19,"registration_number":24},[18],"DEN220065",[20,21,22,23],"","3005580113","3007766601","3027502350",[20,21,22,23],"N","Ineligible","2026-08-18T05:52:49.347546+00:00","2026-08-24T02:00:47.318533+00:00",0,null,1,[],[34,43,52,61,69,78,85,93,99,106],{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":40,"vector_similarity":41,"score":42},698,"透析装置用血液量検知器","Ⅲ","32127000",0.235294,0.17284,0.710348,0.0288981,{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},2987,"カプセル型撮像及び追跡装置","Ⅱ","71027000",0.208333,0.233898,0.787217,0.0284416,{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":58,"vector_similarity":59,"score":60},3376,"呼気ガスディテクタ","Ⅰ","70087000",0.230769,0.209877,0.676092,0.0250623,{"medical_device_id":62,"generic_name":63,"class_classification":37,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":68},346,"神経探知モジュール","37246003",0.342857,0.189003,0.622526,0.0163934,{"medical_device_id":70,"generic_name":71,"class_classification":72,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":77},74,"冠状静脈洞内血液採取用カテーテル","Ⅳ","70277000",0.291667,0.164557,0.606036,0.016129,{"medical_device_id":79,"generic_name":80,"class_classification":55,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":77},3515,"便潜血測定装置","70182000",0.115385,0.204545,0.728652,{"medical_device_id":86,"generic_name":87,"class_classification":46,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},2356,"献血用血液ロッカ","36405000",0.277778,0.211207,0.599096,0.015873,{"medical_device_id":94,"generic_name":95,"class_classification":55,"jmdn_code":96,"name_similarity":29,"definition_similarity":97,"vector_similarity":98,"score":92},3552,"ヘモグロビン分析装置","35481000",0.292208,0.72774,{"medical_device_id":100,"generic_name":101,"class_classification":55,"jmdn_code":102,"name_similarity":29,"definition_similarity":103,"vector_similarity":104,"score":105},3544,"血栓分析装置","36746000",0.26,0.717364,0.015625,{"medical_device_id":107,"generic_name":108,"class_classification":55,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":105},4048,"歯科アマルガム用カプセル","35791000",0.27027,0.121827,0.598414,[],{"510k":115,"classification":116,"enforcement":117,"event":118,"pma":119,"warning_letter":120},"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":122,"definition_ja":123,"commentary_ja":124,"model_name":125,"source_hash":126,"reviewed_by":30,"reviewed_at":30,"created_at":127,"updated_at":127},"消化管出血検知用カプセル","摂取型消化管出血検知カプセル装置は、分光光度法（光吸収技術）を用いて消化管内における血液の有無を検知する処方用医療機器である。","本品は米国においてクラスIIに分類されており、市販前届出（510(k)）の対象として、既存の同等品との実質的同等性を示すことで市販が認められる区分に該当します。クラスIIIの機器に求められる市販前承認（PMA）と比べて、相対的にリスクが低いと位置づけられている医療機器であることを意味します。","claude-sonnet-5","c6acbe7494fa353f34319b6b26942e8cc7f7df3fc29a8cd622e47bc109b1b4a7","2026-08-24T03:33:38.802601+00:00",{"product_code":6,"summary_ja":129,"stats":130,"stats_hash":139,"model_name":125,"created_at":140,"updated_at":140},"本製品コードの510(k)届出は累計1件で、参入企業数は1社、直近5年間でも1件の届出が確認されており、最新の判定は2023年2月です。PMAの申請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、いずれも累計0件であり、報告は確認されていません。",{"pma":131,"k510":132,"as_of":134,"events":135,"recalls":136,"top_problems":138},{"latest":30,"originals":29,"supplements":29},{"total":31,"last5y":31,"latest":133,"applicants":31},"2023-02-24","2026-08",{"death":29,"other":29,"total":29,"injury":29,"last5y":29,"malfunction":29,"latest_month":30},{"total":29,"last5y":29,"latest":30,"class_i":29,"class_ii":29,"class_iii":29,"top_root_causes":137},[],[],"1076753542a7af83f37b703a6dd10c110bc7b14b8cfb39b9e858527dba88ae24","2026-08-24T05:21:03.140427+00:00",{"items":142,"total":29},[],{"items":144,"total":31},[145],{"k_number":18,"device_name":146,"applicant":147,"decision_date":133,"clearance_type":148,"decision_code":149,"statement_or_summary":30},"Pill Sense System","Enterasense , Ltd.","Direct","DENG",{"items":151,"total":29},[]]