[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PCT":3},{"classification":4,"mappedDevices":43,"similarCandidates":44,"relatedClassifications":127,"syncDates":128},{"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":36,"updated_at":37,"recall_count":38,"latest_recall_date":39,"k510_count":40,"pma_count":41,"event_count":42},7080,"PCT","Prostate Immobilizer Rectal Balloon","2","892.5720","RA","Radiology","1","Intended to be used for the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose is to stabilize the prostate during computed tomography (CT) exam, X-ray, or radiation therapy (RT) treatments. The placement of the balloon requires a physician or a physician-directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":32,"device_class":8,"implant_flag":33,"product_code":6,"review_panel":10,"gmp_exempt_flag":33,"third_party_flag":34,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":32,"life_sustain_support_flag":33,"medical_specialty_description":11,"summary_malfunction_reporting":35},{"k_number":17,"fei_number":23,"registration_number":31},[18,19,20,21,22],"DEN130036","K223249","K150234","K180478","K141958",[24,25,26,27,28,29,30],"1000523114","3006948745","3015431711","3008513105","3014246639","3040865950","3007963782",[24,25,26,27,28,29,30],"","N","Y","Eligible","2026-08-18T05:52:53.878886+00:00","2026-08-18T22:05:38.961415+00:00",2,"2025-03-26",5,0,1,[],[45,54,62,70,78,86,95,102,110,118],{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":50,"definition_similarity":51,"vector_similarity":52,"score":53},2102,"直腸括約筋バルーン","Ⅱ","17781000",0.244898,0.161812,0.763112,0.0325225,{"medical_device_id":55,"generic_name":56,"class_classification":48,"jmdn_code":57,"name_similarity":58,"definition_similarity":59,"vector_similarity":60,"score":61},1919,"腸管用バルーンカテーテル","70237000",0.207547,0.157051,0.713847,0.0305504,{"medical_device_id":63,"generic_name":64,"class_classification":48,"jmdn_code":65,"name_similarity":66,"definition_similarity":67,"vector_similarity":68,"score":69},1314,"直腸向け超音波診断用プローブ","40772000",0.2,0.208602,0.7117,0.0305361,{"medical_device_id":71,"generic_name":72,"class_classification":48,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":77},2054,"回腸瘻用直腸カテーテル","40099000",0.192308,0.201166,0.689844,0.0277831,{"medical_device_id":79,"generic_name":80,"class_classification":48,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":85},2053,"直腸用カテーテル","10746000",0.181818,0.146429,0.700101,0.0272059,{"medical_device_id":87,"generic_name":88,"class_classification":89,"jmdn_code":90,"name_similarity":91,"definition_similarity":92,"vector_similarity":93,"score":94},3679,"血管形成バルーン用加圧器","Ⅰ","17541010",0.160714,0.228495,0.684961,0.0248918,{"medical_device_id":96,"generic_name":97,"class_classification":48,"jmdn_code":98,"name_similarity":82,"definition_similarity":99,"vector_similarity":100,"score":101},1932,"バリウム注腸向け直腸用カテーテル","34912000",0.205962,0.674205,0.0245215,{"medical_device_id":103,"generic_name":104,"class_classification":48,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":109},2569,"単回使用直腸前立腺肥大症用ハイパサーミア装置カテーテル","42454000",0.178571,0.191257,0.67137,0.0239316,{"medical_device_id":111,"generic_name":112,"class_classification":48,"jmdn_code":113,"name_similarity":114,"definition_similarity":115,"vector_similarity":116,"score":117},1914,"直腸用チューブ","14227000",0.170732,0.124542,0.681866,0.0234311,{"medical_device_id":119,"generic_name":120,"class_classification":121,"jmdn_code":122,"name_similarity":123,"definition_similarity":124,"vector_similarity":125,"score":126},100,"リトラクトバルーン","Ⅳ","70294000",0.244444,0.2375,0.670919,0.0163934,[],{"510k":129,"classification":130,"enforcement":131,"event":132,"pma":133,"warning_letter":134},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-18T22:42:53.076+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]