[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-SCW":3},{"classification":4,"mappedDevices":31,"similarCandidates":32,"relatedClassifications":113,"syncDates":117,"translation":124,"marketSummary":131,"recalls":145,"k510s":147,"pmas":157},{"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":26,"updated_at":27,"recall_count":28,"latest_recall_date":29,"k510_count":30,"pma_count":28,"event_count":28},2507,"SCW","Digital Prismatic Correction","1","886.1655","OP","Ophthalmic","4","The device is intended to provide digital image adjustments in a display system in accordance with a user’s prism prescription. The device can be used in conjunction with optical lenses for refractive correction.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":23,"device_class":8,"implant_flag":24,"product_code":6,"review_panel":10,"gmp_exempt_flag":24,"third_party_flag":24,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":23,"life_sustain_support_flag":24,"medical_specialty_description":11,"summary_malfunction_reporting":25},{"k_number":17,"fei_number":20,"registration_number":22},[18,19],"K250143","K242058",[21],"3014343954",[21],"","N","Ineligible","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:48.758894+00:00",0,null,2,[],[33,42,51,59,67,75,83,91,98,106],{"medical_device_id":34,"generic_name":35,"class_classification":36,"jmdn_code":37,"name_similarity":38,"definition_similarity":39,"vector_similarity":40,"score":41},1055,"再使用可能な視力補正用コンタクトレンズ","Ⅲ","36055000",0.175439,0.233577,0.734862,0.0283242,{"medical_device_id":43,"generic_name":44,"class_classification":45,"jmdn_code":46,"name_similarity":47,"definition_similarity":48,"vector_similarity":49,"score":50},1269,"パノラマ用デジタル式X線センサ","Ⅱ","70004020",0.2,0.260223,0.679537,0.0282832,{"medical_device_id":52,"generic_name":53,"class_classification":36,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},1056,"単回使用視力補正用コンタクトレンズ","37581000",0.169492,0.25641,0.709794,0.0266106,{"medical_device_id":60,"generic_name":61,"class_classification":45,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},2925,"家庭用エア式指圧代用器","70982000",0.288462,0.191882,0.563599,0.0163934,{"medical_device_id":68,"generic_name":69,"class_classification":70,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":66},4379,"眼鏡レンズ","Ⅰ","35957000",0.0232558,0.302632,0.767211,{"medical_device_id":76,"generic_name":77,"class_classification":70,"jmdn_code":78,"name_similarity":79,"definition_similarity":80,"vector_similarity":81,"score":82},3313,"放射線防護用カラー","38358000",0.227273,0.193467,0.435338,0.016129,{"medical_device_id":84,"generic_name":85,"class_classification":36,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},1054,"再使用可能な視力補正用色付コンタクトレンズ","32803000",0.15873,0.234848,0.733631,0.015873,{"medical_device_id":92,"generic_name":93,"class_classification":70,"jmdn_code":94,"name_similarity":95,"definition_similarity":96,"vector_similarity":97,"score":90},3316,"放射線防護用帽子","70041000",0.214286,0.20155,0.480666,{"medical_device_id":99,"generic_name":100,"class_classification":45,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},1417,"単回使用圧平眼圧計用プリズム","70059000",0.132353,0.233333,0.727275,0.015625,{"medical_device_id":107,"generic_name":108,"class_classification":45,"jmdn_code":109,"name_similarity":47,"definition_similarity":110,"vector_similarity":111,"score":112},1212,"据置型デジタル式汎用X線診断装置","37645010",0.222222,0.634304,0.0153846,[114],{"product_code":115,"device_name":116,"device_class":8,"k510_count":28},"HKT","Prism, Fresnel, Ophthalmic",{"510k":118,"classification":119,"enforcement":120,"event":121,"pma":122,"warning_letter":123},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":125,"definition_ja":126,"commentary_ja":127,"model_name":128,"source_hash":129,"reviewed_by":29,"reviewed_at":29,"created_at":130,"updated_at":130},"デジタルプリズム矯正装置","本装置は、使用者のプリズム処方に従い、表示システムにおいてデジタル画像調整を行うことを目的とする。本装置は、屈折矯正のための光学レンズと併用することができる。","本機器は米国の医療機器規制上クラスIに分類されており、市販前届出（510(k)）が免除される機器です。クラスIは一般的な管理（general controls）により安全性及び有効性が十分に確保できると判断される低リスク機器に適用される区分であり、市販前に510(k)による審査を受ける必要がありません。","claude-sonnet-5","8cdc4b614731162ca99cdbda92f89b9d548d1598b1f0c6f0aa99192d0448e1c8","2026-08-24T03:37:43.881155+00:00",{"product_code":6,"summary_ja":132,"stats":133,"stats_hash":143,"model_name":128,"created_at":144,"updated_at":144},"本製品は届出免除区分ですが、510(k)の累計件数は2件、参入企業数は1社となっており、直近5年でも2件の届出が確認されています。不具合報告および回収については、いずれも累計件数0件で、報告・実施事例は確認されていません。",{"pma":134,"k510":135,"as_of":138,"events":139,"recalls":140,"top_problems":142},{"latest":29,"originals":28,"supplements":28},{"total":30,"last5y":30,"latest":136,"applicants":137},"2025-06-23",1,"2026-08",{"death":28,"other":28,"total":28,"injury":28,"last5y":28,"malfunction":28,"latest_month":29},{"total":28,"last5y":28,"latest":29,"class_i":28,"class_ii":28,"class_iii":28,"top_root_causes":141},[],[],"c73e8a642d7e50919329f05cbf2d2779a98d5104def670a3db80548f0bb6c443","2026-08-24T05:23:16.025025+00:00",{"items":146,"total":28},[],{"items":148,"total":30},[149,155],{"k_number":18,"device_name":150,"applicant":151,"decision_date":136,"clearance_type":152,"decision_code":153,"statement_or_summary":154},"Digital Prism Correction Feature (DPCF)","Apple, Inc.","Traditional","SESE","Summary",{"k_number":19,"device_name":150,"applicant":151,"decision_date":156,"clearance_type":152,"decision_code":153,"statement_or_summary":154},"2024-10-21",{"items":158,"total":28},[]]