[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OMJ":3},{"classification":4,"mappedDevices":30,"similarCandidates":31,"relatedClassifications":113,"syncDates":154},{"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":25,"updated_at":26,"recall_count":27,"latest_recall_date":28,"k510_count":29,"pma_count":27,"event_count":27},1950,"OMJ","Chest X-Ray Computer Aided Detection","2","892.2050","RA","Radiology","1","To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":22,"device_class":8,"implant_flag":23,"product_code":6,"review_panel":10,"gmp_exempt_flag":23,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":22,"life_sustain_support_flag":23,"medical_specialty_description":11,"summary_malfunction_reporting":24},{"k_number":17,"fei_number":19,"registration_number":21},[18],"K042408",[20],"3004857110",[20],"","N","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-18T22:05:38.961415+00:00",0,null,1,[],[32,41,49,58,66,74,82,90,97,105],{"medical_device_id":33,"generic_name":34,"class_classification":35,"jmdn_code":36,"name_similarity":37,"definition_similarity":38,"vector_similarity":39,"score":40},1275,"アーム型X線CT診断装置","Ⅱ","70006000",0.241935,0.139535,0.714435,0.028612,{"medical_device_id":42,"generic_name":43,"class_classification":35,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},3026,"X線CT診断装置用プログラム","37619012",0.208955,0.104418,0.732244,0.0280833,{"medical_device_id":50,"generic_name":51,"class_classification":52,"jmdn_code":53,"name_similarity":54,"definition_similarity":55,"vector_similarity":56,"score":57},4409,"X線造影材入りスポンジ","Ⅰ","13705000",0.25,0.110656,0.703864,0.0274927,{"medical_device_id":59,"generic_name":60,"class_classification":35,"jmdn_code":61,"name_similarity":62,"definition_similarity":63,"vector_similarity":64,"score":65},1341,"X線平面検出器出力読取式デジタルラジオグラフ","70026000",0.191781,0.121311,0.7305,0.0263975,{"medical_device_id":67,"generic_name":68,"class_classification":35,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":73},3027,"アーム型X線CT診断装置用プログラム","70006012",0.202703,0.0987124,0.723059,0.0263569,{"medical_device_id":75,"generic_name":76,"class_classification":35,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},1338,"コンピューテッドラジオグラフ","70023000",0.212766,0.129496,0.704114,0.0255788,{"medical_device_id":83,"generic_name":84,"class_classification":35,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},3016,"胸部集団検診用X線診断装置用プログラム","37627052",0.0736842,0.0785124,0.75799,0.0163934,{"medical_device_id":91,"generic_name":92,"class_classification":52,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":89},4411,"X線造影材入りガーゼ","32374000",0.255319,0.106996,0.602413,{"medical_device_id":98,"generic_name":99,"class_classification":35,"jmdn_code":100,"name_similarity":101,"definition_similarity":102,"vector_similarity":103,"score":104},3019,"胸部集団検診用一体型X線診断装置用プログラム","37627072",0.0673077,0.0846774,0.742032,0.016129,{"medical_device_id":106,"generic_name":107,"class_classification":35,"jmdn_code":108,"name_similarity":109,"definition_similarity":110,"vector_similarity":111,"score":112},1340,"電子管出力読取式デジタルラジオグラフ","70025000",0.0821918,0.112948,0.741748,0.015873,[114,118,122,126,130,134,138,142,146,150],{"product_code":115,"device_name":116,"device_class":8,"k510_count":117},"LLZ","System, Image Processing, Radiological",2283,{"product_code":119,"device_name":120,"device_class":8,"k510_count":121},"QIH","Automated Radiological Image Processing Software",319,{"product_code":123,"device_name":124,"device_class":8,"k510_count":125},"PGY","Display, Diagnostic Radiology",135,{"product_code":127,"device_name":128,"device_class":8,"k510_count":129},"NFJ","System, Image Management, Ophthalmic",53,{"product_code":131,"device_name":132,"device_class":8,"k510_count":133},"QKB","Radiological Image Processing Software For Radiation Therapy",48,{"product_code":135,"device_name":136,"device_class":8,"k510_count":137},"OEB","Lung Computed Tomography System, Computer-Aided Detection",20,{"product_code":139,"device_name":140,"device_class":8,"k510_count":141},"PZO","Software For Visualization Of Vascular Anatomy And Intravascular Devices",10,{"product_code":143,"device_name":144,"device_class":8,"k510_count":145},"QTZ","Radiological Image Processing Software For Ablation Therapy Planning And Evaluation",9,{"product_code":147,"device_name":148,"device_class":8,"k510_count":149},"NWE","Colon Computed Tomography System, Computer Aided Detection",4,{"product_code":151,"device_name":152,"device_class":8,"k510_count":153},"QQE","Image Management Software For Planning Of Otologic And Neurotologic Procedures",3,{"510k":155,"classification":156,"enforcement":157,"event":158,"pma":159,"warning_letter":160},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]