[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NUI":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":116,"syncDates":152},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":26,"updated_at":27,"recall_count":28,"latest_recall_date":29,"k510_count":30,"pma_count":28,"event_count":31},2658,"NUI","Ultrasound, Infusion, System","2","870.1200","CV","Cardiovascular","NE","1","For regional infusion of contrast materials into selected vessels in the neuro-vasculature.  The device may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.",false,{"openfda":17,"definition":14,"device_name":7,"review_code":23,"device_class":8,"implant_flag":24,"product_code":6,"review_panel":12,"gmp_exempt_flag":24,"third_party_flag":24,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":23,"life_sustain_support_flag":24,"medical_specialty_description":11,"summary_malfunction_reporting":25},{"k_number":18},[19,20,21,22],"K051225","K062508","K053437","K041826","","N","Ineligible","2026-08-18T05:52:50.495594+00:00","2026-08-18T22:05:38.961415+00:00",0,null,4,3,[],[34,43,52,60,68,76,84,92,100,109],{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":40,"vector_similarity":41,"score":42},950,"超音波吸引器","Ⅲ","37776000",0.444444,0.214789,0.734572,0.0298774,{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},1300,"循環器用超音波画像診断装置","Ⅱ","40763000",0.358491,0.209424,0.755532,0.02886,{"medical_device_id":53,"generic_name":54,"class_classification":37,"jmdn_code":55,"name_similarity":56,"definition_similarity":57,"vector_similarity":58,"score":59},1128,"集束超音波治療器","57888003",0.418605,0.181818,0.716492,0.0282587,{"medical_device_id":61,"generic_name":62,"class_classification":46,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},1302,"眼科用超音波画像診断装置","11389000",0.422222,0.172414,0.70307,0.0276515,{"medical_device_id":69,"generic_name":70,"class_classification":37,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},975,"超音波式ハイパサーミアシステム","40781000",0.45,0.182306,0.698091,0.0271193,{"medical_device_id":77,"generic_name":78,"class_classification":46,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},1400,"超音波ドプラ血流測定装置","40759000",0.310345,0.209497,0.719118,0.0257468,{"medical_device_id":85,"generic_name":86,"class_classification":46,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},1294,"汎用超音波画像診断装置","40761000",0.351852,0.191011,0.712447,0.0256579,{"medical_device_id":93,"generic_name":94,"class_classification":46,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},1301,"膀胱用超音波画像診断装置","70013000",0.413043,0.166667,0.696455,0.0255217,{"medical_device_id":101,"generic_name":102,"class_classification":103,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":108},96,"中心循環系血管内超音波カテーテル","Ⅳ","70289004",0.213115,0.254464,0.767389,0.0163934,{"medical_device_id":110,"generic_name":111,"class_classification":46,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":108},1354,"超音波装置ワークステーション","40936000",0.477273,0.194595,0.659561,[117,121,125,129,133,137,140,143,146,149],{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"DQO","Catheter, Intravascular, Diagnostic",501,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"OBJ","Catheter, Ultrasound, Intravascular",79,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"OWQ","Reprocessed Intravascular Ultrasound Catheter",31,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"OGZ","Catheter, Intravascular, Plaque Morphology Evaluation",9,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"NLI","Catheter, Angiography, Reprocessed",1,{"product_code":138,"device_name":139,"device_class":8,"k510_count":136},"OBI","Catheter, Pressure Monitoring, Cardiac",{"product_code":141,"device_name":142,"device_class":8,"k510_count":28},"OES","Cardiac Catheterization Kit",{"product_code":144,"device_name":145,"device_class":8,"k510_count":28},"OEZ","Cardiovascular Procedure Kit",{"product_code":147,"device_name":148,"device_class":8,"k510_count":28},"OFN","Winged Intravenous Catheterization Kit",{"product_code":150,"device_name":151,"device_class":8,"k510_count":28},"ORD","Optical Coherence Tomography, Intravascular Catheter",{"510k":153,"classification":154,"enforcement":155,"event":156,"pma":157,"warning_letter":158},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:29:12.941+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]