[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PDK":3},{"classification":4,"mappedDevices":34,"similarCandidates":35,"relatedClassifications":116,"syncDates":117,"translation":124,"marketSummary":131,"recalls":145,"k510s":147,"pmas":160},{"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":29,"updated_at":30,"recall_count":31,"latest_recall_date":32,"k510_count":33,"pma_count":31,"event_count":31},6362,"PDK","Cream For X-Ray Attenuation","2","892.6510","RA","Radiology","1","The x-ray attenuating cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a gloved hand, followed by donning a second glove. The X-ray attenuating cream is intended to be used during medical procedures where its necessary for hands to be exposed to radiation to offer some degree of protection from radiation exposure.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":25,"device_class":8,"implant_flag":26,"product_code":6,"review_panel":10,"gmp_exempt_flag":26,"third_party_flag":27,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":25,"life_sustain_support_flag":26,"medical_specialty_description":11,"summary_malfunction_reporting":28},{"k_number":17,"fei_number":20,"registration_number":24},[18,19],"K133684","DEN120022",[21,22,23],"2523891","3009688745","2245304",[21,22,23],"","N","Y","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-24T02:00:49.169481+00:00",0,null,2,[],[36,45,52,60,68,77,84,93,101,108],{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":42,"vector_similarity":43,"score":44},3305,"放射線防護用ミトン","Ⅰ","38365000",0.177778,0.281843,0.736852,0.0298277,{"medical_device_id":46,"generic_name":47,"class_classification":39,"jmdn_code":48,"name_similarity":41,"definition_similarity":49,"vector_similarity":50,"score":51},3309,"放射線防護用顔面防護具","38363000",0.267218,0.664553,0.0266667,{"medical_device_id":53,"generic_name":54,"class_classification":39,"jmdn_code":55,"name_similarity":56,"definition_similarity":57,"vector_similarity":58,"score":59},3276,"X線被曝低減装置","70037000",0.18,0.217557,0.648282,0.0237693,{"medical_device_id":61,"generic_name":62,"class_classification":39,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},3277,"X線自動露出制御器","34311000",0.173077,0.226837,0.652957,0.0231283,{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":76},596,"頭蓋骨固定用クランプ","Ⅲ","70500000",0.232558,0.176471,0.489233,0.0163934,{"medical_device_id":78,"generic_name":79,"class_classification":39,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":76},3304,"放射線防護用手袋","38364000",0.12766,0.287129,0.776368,{"medical_device_id":85,"generic_name":86,"class_classification":87,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},3150,"骨X線吸収測定装置用プログラム","Ⅱ","37625032",0.218182,0.251656,0.557735,0.016129,{"medical_device_id":94,"generic_name":95,"class_classification":39,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":100},3290,"静止X線用グリッド","40915000",0.219512,0.197368,0.622377,0.015873,{"medical_device_id":102,"generic_name":103,"class_classification":39,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":100},3306,"放射線防護用局所手防護具","38366000",0.132075,0.282051,0.725997,{"medical_device_id":109,"generic_name":110,"class_classification":39,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},3265,"自動X線フィルムチェンジャ","35831000",0.212766,0.23822,0.606418,0.015625,[],{"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":32,"reviewed_at":32,"created_at":130,"updated_at":130},"X線減弱クリーム","X線減弱クリームは、放射線遮蔽材として使用することを意図したものである。使用者の手に手袋を着用する前に塗布すること、または手袋を着用した手に塗布した後にさらにもう一枚の手袋を着用することを意図している。X線減弱クリームは、手が放射線に曝露される必要のある医療処置の間に使用され、放射線曝露からある程度の防護を提供することを意図している。","本品は米国FDAの規制上クラスIIに分類されており、市販前届出（510(k)）による審査区分の対象となっています。クラスIIは中程度のリスクを有する医療機器に適用される区分であり、有効性及び安全性を担保するために既存の同等品（プレディケイトデバイス）との実質的同等性を示すことが求められます。","claude-sonnet-5","5755823be5d8abc9f9ef73f49c9a4e7900fdbcd88fba4cc386438c5f85bad76a","2026-08-24T02:30:13.381035+00:00",{"product_code":6,"summary_ja":132,"stats":133,"stats_hash":143,"model_name":128,"created_at":144,"updated_at":144},"510(k)については累計2件が確認されており、参入企業数は1社となっています。直近5年間の届出はなく、最新の判定は2014年1月です。不具合報告および回収については、いずれも累計件数が0件で、確認されていません。",{"pma":134,"k510":135,"as_of":138,"events":139,"recalls":140,"top_problems":142},{"latest":32,"originals":31,"supplements":31},{"total":33,"last5y":31,"latest":136,"applicants":137},"2014-01-13",1,"2026-08",{"death":31,"other":31,"total":31,"injury":31,"last5y":31,"malfunction":31,"latest_month":32},{"total":31,"last5y":31,"latest":32,"class_i":31,"class_ii":31,"class_iii":31,"top_root_causes":141},[],[],"7d3c8da9c8cb84dbd67a760155cd167d703b433cd56a0b0b482051c816821f9a","2026-08-24T05:09:58.149854+00:00",{"items":146,"total":31},[],{"items":148,"total":33},[149,155],{"k_number":18,"device_name":150,"applicant":151,"decision_date":136,"clearance_type":152,"decision_code":153,"statement_or_summary":154},"ULTRABLOX","Bloxr Corporation","Traditional","SESE","Summary",{"k_number":19,"device_name":156,"applicant":151,"decision_date":157,"clearance_type":158,"decision_code":159,"statement_or_summary":32},"X-RAY ATTENUATING CREAM","2013-05-09","Direct","DENG",{"items":161,"total":31},[]]