[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NQQ":3},{"classification":4,"mappedDevices":108,"similarCandidates":109,"relatedClassifications":192,"syncDates":211},{"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":101,"updated_at":102,"recall_count":103,"latest_recall_date":104,"k510_count":105,"pma_count":106,"event_count":107},1346,"NQQ","System, Imaging, Optical Coherence Tomography (Oct)","2","892.1560","RA","Radiology","SU","1","This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.",false,{"openfda":17,"definition":14,"device_name":7,"review_code":97,"device_class":8,"implant_flag":98,"product_code":6,"review_panel":12,"gmp_exempt_flag":98,"third_party_flag":99,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":97,"life_sustain_support_flag":98,"medical_specialty_description":11,"summary_malfunction_reporting":100},{"k_number":18,"fei_number":65,"registration_number":94},[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64],"K121195","K190404","K112770","K242239","K253101","K123369","K152120","K183320","K250684","K160240","K093520","K132800","K253459","K102599","K240610","K042894","K243016","K242098","K162466","K171560","K150878","K251730","K203578","K093857","K143678","K201552","K252851","K151286","K182616","K120800","K182261","K153479","K232386","K150237","K111201","K033783","K133209","K251198","K191117","K221257","K160878","K153283","K192922","K242924","K210458","K230691",[66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93],"3007603861","2024311","3042970803","3011578544","3012198618","2245304","2024168","3027259266","3038165043","3009882464","1221051","3004091615","3021630097","3012179728","3017654247","3013440400","1000203464","3013276158","3004837686","3013351723","3042929028","3005228872","1220477","3043527620","3009600098","2246552","3000206435","3010126772",[66,67,68,69,95,70,71,72,73,74,75,76,77,96,78,79,80,81,83,84,85,86,87,88,89,90,91,93],"2030624","9680579","","N","Y","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-18T22:05:38.961415+00:00",3,"2018-05-16",46,0,69,[],[110,119,128,136,144,152,160,168,176,184],{"medical_device_id":111,"generic_name":112,"class_classification":113,"jmdn_code":114,"name_similarity":115,"definition_similarity":116,"vector_similarity":117,"score":118},1357,"OCT画像診断装置","Ⅱ","70031000",1,0.178117,0.851066,0.0327869,{"medical_device_id":120,"generic_name":121,"class_classification":122,"jmdn_code":123,"name_similarity":124,"definition_similarity":125,"vector_similarity":126,"score":127},72,"血管内光断層撮影用カテーテル","Ⅳ","70275000",0.441176,0.177632,0.75798,0.032002,{"medical_device_id":129,"generic_name":130,"class_classification":113,"jmdn_code":131,"name_similarity":132,"definition_similarity":133,"vector_similarity":134,"score":135},1299,"乳房用超音波画像診断装置","40764000",0.328358,0.173653,0.740496,0.0307984,{"medical_device_id":137,"generic_name":138,"class_classification":113,"jmdn_code":139,"name_similarity":140,"definition_similarity":141,"vector_similarity":142,"score":143},1302,"眼科用超音波画像診断装置","11389000",0.253731,0.185915,0.794645,0.0294624,{"medical_device_id":145,"generic_name":146,"class_classification":113,"jmdn_code":147,"name_similarity":148,"definition_similarity":149,"vector_similarity":150,"score":151},1483,"心臓画像処理装置","70069000",0.296296,0.209302,0.688847,0.0276515,{"medical_device_id":153,"generic_name":154,"class_classification":113,"jmdn_code":155,"name_similarity":156,"definition_similarity":157,"vector_similarity":158,"score":159},1298,"産婦人科用超音波画像診断装置","40762000",0.228916,0.167139,0.74287,0.0271493,{"medical_device_id":161,"generic_name":162,"class_classification":113,"jmdn_code":163,"name_similarity":164,"definition_similarity":165,"vector_similarity":166,"score":167},1301,"膀胱用超音波画像診断装置","70013000",0.214286,0.205298,0.747437,0.0269886,{"medical_device_id":169,"generic_name":170,"class_classification":113,"jmdn_code":171,"name_similarity":172,"definition_similarity":173,"vector_similarity":174,"score":175},1229,"診断用直線X線断層撮影装置","37648000",0.271429,0.163158,0.68395,0.0259893,{"medical_device_id":177,"generic_name":178,"class_classification":113,"jmdn_code":179,"name_similarity":180,"definition_similarity":181,"vector_similarity":182,"score":183},1685,"内視鏡ビデオ画像システム","35616000",0.234375,0.177852,0.682977,0.0236894,{"medical_device_id":185,"generic_name":186,"class_classification":113,"jmdn_code":187,"name_similarity":188,"definition_similarity":189,"vector_similarity":190,"score":191},1293,"移動型超音波画像診断装置","36208000",0.230769,0.179941,0.680517,0.0231593,[193,197,201,205,208],{"product_code":194,"device_name":195,"device_class":8,"k510_count":196},"IYO","System, Imaging, Pulsed Echo, Ultrasonic",894,{"product_code":198,"device_name":199,"device_class":8,"k510_count":200},"LWI","Ultrasound, Sinus",4,{"product_code":202,"device_name":203,"device_class":8,"k510_count":204},"QJG","Device System, Imaging, Tympanic Membrane And Middle Ear",2,{"product_code":206,"device_name":207,"device_class":8,"k510_count":115},"SGH","Ultrasound Imaging For Vascular Access For Hemodialysis",{"product_code":209,"device_name":210,"device_class":8,"k510_count":106},"OIJ","Biopsy Needle Guide Kit",{"510k":212,"classification":213,"enforcement":214,"event":215,"pma":216,"warning_letter":217},"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","2026-08-18T06:42:29.411+00:00"]