[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HEJ":3},{"classification":4,"mappedDevices":23,"similarCandidates":24,"relatedClassifications":95,"syncDates":126},{"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":20,"updated_at":20,"recall_count":21,"latest_recall_date":22,"k510_count":21,"pma_count":21,"event_count":21},991,"HEJ","Monitor, Hemic Sound, Ultrasonic","2","884.2660","OB","Obstetrics\u002FGynecology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":17,"product_code":6,"review_panel":10,"gmp_exempt_flag":17,"third_party_flag":18,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":17,"medical_specialty_description":11,"summary_malfunction_reporting":19},{},"N","Y","Ineligible","2026-08-18T05:52:48.222586+00:00",0,null,[],[25,33,40,47,54,61,68,74,82,89],{"medical_device_id":26,"generic_name":27,"class_classification":28,"jmdn_code":29,"name_similarity":30,"definition_similarity":21,"vector_similarity":31,"score":32},1420,"胎児超音波心音計","Ⅱ","35068000",0.326087,0.681271,0.0325225,{"medical_device_id":34,"generic_name":35,"class_classification":28,"jmdn_code":36,"name_similarity":37,"definition_similarity":21,"vector_similarity":38,"score":39},1380,"超音波聴診器","13756000",0.3,0.673449,0.0310096,{"medical_device_id":41,"generic_name":42,"class_classification":28,"jmdn_code":43,"name_similarity":44,"definition_similarity":21,"vector_similarity":45,"score":46},1321,"超音波装置用シンクロナイザ","35460000",0.288889,0.650211,0.0280392,{"medical_device_id":48,"generic_name":49,"class_classification":28,"jmdn_code":50,"name_similarity":51,"definition_similarity":21,"vector_similarity":52,"score":53},1392,"超音波心拍出量計","17190000",0.255319,0.653122,0.0255168,{"medical_device_id":55,"generic_name":56,"class_classification":28,"jmdn_code":57,"name_similarity":58,"definition_similarity":21,"vector_similarity":59,"score":60},1323,"超音波プローブポジショニングユニット","40786000",0.270833,0.644273,0.0253327,{"medical_device_id":62,"generic_name":63,"class_classification":28,"jmdn_code":64,"name_similarity":65,"definition_similarity":21,"vector_similarity":66,"score":67},1313,"膣向け超音波診断用プローブ","40771000",0.255814,0.648283,0.024563,{"medical_device_id":69,"generic_name":70,"class_classification":28,"jmdn_code":71,"name_similarity":21,"definition_similarity":21,"vector_similarity":72,"score":73},1618,"トノスコープ","14069000",0.686179,0.0163934,{"medical_device_id":75,"generic_name":76,"class_classification":77,"jmdn_code":78,"name_similarity":79,"definition_similarity":21,"vector_similarity":80,"score":81},951,"超音波手術器","Ⅲ","70651000",0.325,0.628773,0.016129,{"medical_device_id":83,"generic_name":84,"class_classification":77,"jmdn_code":85,"name_similarity":86,"definition_similarity":21,"vector_similarity":87,"score":88},949,"超音波ナイフ","36540000",0.315789,0.62379,0.015873,{"medical_device_id":90,"generic_name":91,"class_classification":28,"jmdn_code":92,"name_similarity":93,"definition_similarity":21,"vector_similarity":94,"score":88},1399,"超音波血流計","10432000",0.244444,0.678947,[96,100,104,108,112,116,120,123],{"product_code":97,"device_name":98,"device_class":8,"k510_count":99},"KNG","Monitor, Ultrasonic, Fetal",60,{"product_code":101,"device_name":102,"device_class":8,"k510_count":103},"MAA","Monitor, Fetal Doppler Ultrasound",9,{"product_code":105,"device_name":106,"device_class":8,"k510_count":107},"HEL","Monitor, Heart Rate, Fetal, Ultrasonic",7,{"product_code":109,"device_name":110,"device_class":8,"k510_count":111},"HEK","Monitor, Heart Sound, Fetal, Ultrasonic",5,{"product_code":113,"device_name":114,"device_class":8,"k510_count":115},"HEP","Monitor, Blood-Flow, Ultrasonic",4,{"product_code":117,"device_name":118,"device_class":8,"k510_count":119},"HEI","Monitor, Heart-Valve Movement, Fetal, Ultrasonic",3,{"product_code":121,"device_name":122,"device_class":8,"k510_count":21},"HEQ","Monitor, Pressure, Arterial, Fetal, Ultrasonic",{"product_code":124,"device_name":125,"device_class":8,"k510_count":21},"LXE","Doppler, Fetal, Ultrasound",{"510k":127,"classification":128,"enforcement":129,"event":130,"pma":131,"warning_letter":132},"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"]