[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QWH":3},{"classification":4,"mappedDevices":36,"similarCandidates":37,"relatedClassifications":116,"syncDates":117},{"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":30,"updated_at":31,"recall_count":32,"latest_recall_date":33,"k510_count":34,"pma_count":35,"event_count":34},6189,"QWH","Prognostic Test For Development Or Progression Of Preeclampsia","2","862.1602","CH","Clinical Chemistry","TX","1","A prognostic test for development or progression of preeclampsia is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples. A prognostic test for development or progression of preeclampsia is indicated as an aid in the risk assessment for the development or progression of preeclampsia. This device is not intended for diagnosis of any disease.",false,{"openfda":17,"definition":14,"device_name":7,"review_code":27,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":12,"gmp_exempt_flag":28,"third_party_flag":28,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":27,"life_sustain_support_flag":28,"medical_specialty_description":11,"summary_malfunction_reporting":29},{"k_number":18,"fei_number":21,"registration_number":25},[19,20],"DEN220027","K241453",[22,23,24],"3002806559","3005847079","3003561301",[26,23,24],"9610126","","N","Ineligible","2026-08-18T05:52:53.233452+00:00","2026-08-18T22:05:38.961415+00:00",1,"2026-04-15",2,0,[],[38,47,55,62,71,79,86,94,101,109],{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":44,"vector_similarity":45,"score":46},1377,"血圧脈波検査装置","Ⅱ","70045000",0.179487,0.186111,0.637388,0.0302135,{"medical_device_id":48,"generic_name":49,"class_classification":41,"jmdn_code":50,"name_similarity":51,"definition_similarity":52,"vector_similarity":53,"score":54},1526,"胎児心臓モニタ","43958000",0.0266667,0.201389,0.648395,0.0163934,{"medical_device_id":56,"generic_name":57,"class_classification":41,"jmdn_code":58,"name_similarity":59,"definition_similarity":60,"vector_similarity":61,"score":54},3114,"血圧脈波検査装置用プログラム","70045012",0.209302,0.259259,0.588499,{"medical_device_id":63,"generic_name":64,"class_classification":65,"jmdn_code":66,"name_similarity":67,"definition_similarity":68,"vector_similarity":69,"score":70},3273,"歯科用自動現像装置","Ⅰ","70035000",0.206897,0.125581,0.484923,0.016129,{"medical_device_id":72,"generic_name":73,"class_classification":41,"jmdn_code":74,"name_similarity":75,"definition_similarity":76,"vector_similarity":77,"score":78},1429,"尿動態測定システム","14307000",0.0493827,0.220844,0.63371,0.015873,{"medical_device_id":80,"generic_name":81,"class_classification":41,"jmdn_code":82,"name_similarity":83,"definition_similarity":84,"vector_similarity":85,"score":78},3087,"発声機能検査装置用プログラム","70103012",0.181818,0.246154,0.540626,{"medical_device_id":87,"generic_name":88,"class_classification":41,"jmdn_code":89,"name_similarity":90,"definition_similarity":91,"vector_similarity":92,"score":93},1406,"子宮内圧力モニタ","33727000",0.0759494,0.214612,0.633186,0.015625,{"medical_device_id":95,"generic_name":96,"class_classification":41,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":93},3179,"中耳加圧装置","47542002",0.183908,0.224561,0.483538,{"medical_device_id":102,"generic_name":103,"class_classification":41,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":108},1480,"産科用出産前期生理学的データ分析装置","43007000",0.076087,0.204082,0.629029,0.0153846,{"medical_device_id":110,"generic_name":111,"class_classification":65,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":108},3298,"画像診断用非自己現像フィルム","40984000",0.185185,0.195312,0.531048,[],{"510k":118,"classification":119,"enforcement":120,"event":121,"pma":122,"warning_letter":123},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-19T04:07:02.603+00:00"]