[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PGU":3},{"classification":4,"mappedDevices":35,"similarCandidates":36,"relatedClassifications":116,"syncDates":538,"translation":545,"marketSummary":552,"recalls":569,"k510s":571,"pmas":579},{"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":34},203,"PGU","Spatial Imaging For Display Of Endoscope Position","2","876.1500","GU","Gastroenterology, Urology","1","To detect and display the shape of an inserted endoscope.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":26,"device_class":8,"implant_flag":27,"product_code":6,"review_panel":10,"gmp_exempt_flag":27,"third_party_flag":27,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":26,"life_sustain_support_flag":27,"medical_specialty_description":11,"summary_malfunction_reporting":28},{"k_number":17,"fei_number":19,"registration_number":23},[18],"K134026",[20,21,22],"3002808148","3002807795","3002964398",[24,20,25],"9610595","8010047","","N","Eligible","2026-08-18T05:52:47.660896+00:00","2026-08-24T02:00:48.095002+00:00",0,null,1,6,[],[37,46,54,61,70,77,85,92,100,108],{"medical_device_id":38,"generic_name":39,"class_classification":40,"jmdn_code":41,"name_similarity":42,"definition_similarity":43,"vector_similarity":44,"score":45},1685,"内視鏡ビデオ画像システム","Ⅱ","35616000",0.261538,0.145594,0.745045,0.0296443,{"medical_device_id":47,"generic_name":48,"class_classification":40,"jmdn_code":49,"name_similarity":50,"definition_similarity":51,"vector_similarity":52,"score":53},1689,"ビデオ硬性腹腔鏡","43053000",0.0724638,0.152344,0.76548,0.0163934,{"medical_device_id":55,"generic_name":56,"class_classification":40,"jmdn_code":57,"name_similarity":58,"definition_similarity":59,"vector_similarity":60,"score":53},3206,"サイズ推定用内視鏡画像診断支援プログラム","71092002",0.301205,0.131707,0.730906,{"medical_device_id":62,"generic_name":63,"class_classification":64,"jmdn_code":65,"name_similarity":66,"definition_similarity":67,"vector_similarity":68,"score":69},1152,"疾患鑑別用内視鏡画像診断支援プログラム","Ⅲ","71066003",0.303371,0.109155,0.680981,0.016129,{"medical_device_id":71,"generic_name":72,"class_classification":40,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":69},1764,"硬性口腔鏡","70155000",0.0952381,0.235714,0.763431,{"medical_device_id":78,"generic_name":79,"class_classification":40,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},1700,"ビデオ軟性口腔鏡","70124000",0.0985916,0.251908,0.75828,0.015873,{"medical_device_id":86,"generic_name":87,"class_classification":40,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":84},3192,"病変検出用内視鏡画像診断支援プログラム","71080002",0.282353,0.144279,0.696792,{"medical_device_id":93,"generic_name":94,"class_classification":40,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},1788,"内視鏡挿入形状検出装置","70161000",0.171429,0.190265,0.757293,0.015625,{"medical_device_id":101,"generic_name":102,"class_classification":103,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":99},3714,"送水吸引チューブ","Ⅰ","70355000",0.267606,0.181034,0.603036,{"medical_device_id":109,"generic_name":110,"class_classification":40,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},1693,"ビデオ軟性食道鏡","38666000",0.0972222,0.21,0.755115,0.0153846,[117,121,125,129,133,137,141,145,149,153,157,161,165,169,173,177,181,185,188,192,195,199,203,207,211,215,218,222,226,230,233,237,241,245,248,251,255,259,262,265,269,273,277,281,284,288,291,294,298,301,305,308,311,314,317,321,325,328,331,334,338,341,344,348,351,354,357,360,363,367,370,373,376,379,382,385,388,392,395,398,401,404,407,410,413,416,419,422,425,428,431,434,437,440,443,446,449,452,455,458,461,464,466,469,472,475,478,481,484,487,490,493,496,499,502,505,508,511,514,517,520,523,526,529,532,535],{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"GCJ","Laparoscope, General & Plastic Surgery",1426,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"NAY","System, Surgical, Computer Controlled Instrument",165,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"FGB","Ureteroscope And Accessories, Flexible\u002FRigid",115,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"FDF","Colonoscope And Accessories, Flexible\u002FRigid",113,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"FED","Endoscopic Access Overtube, Gastroenterology-Urology",102,{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"FET","Endoscopic Video Imaging System\u002FComponent, Gastroenterology-Urology",100,{"product_code":142,"device_name":143,"device_class":8,"k510_count":144},"OCX","Endoscopic Irrigation\u002FSuction System",93,{"product_code":146,"device_name":147,"device_class":8,"k510_count":148},"FAJ","Cystoscope And Accessories, Flexible\u002FRigid",92,{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"FBK","Endoscopic Injection Needle, Gastroenterology-Urology",89,{"product_code":154,"device_name":155,"device_class":8,"k510_count":156},"FDS","Gastroscope And Accessories, Flexible\u002FRigid",76,{"product_code":158,"device_name":159,"device_class":8,"k510_count":160},"OCZ","Endoscopic Grasping\u002FCutting Instrument, Non-Powered",74,{"product_code":162,"device_name":163,"device_class":8,"k510_count":164},"ODC","Endoscope Channel Accessory",72,{"product_code":166,"device_name":167,"device_class":8,"k510_count":168},"OCW","Endoscopic Tissue Approximation Device",70,{"product_code":170,"device_name":171,"device_class":8,"k510_count":172},"OWN","Confocal Optical Imaging",62,{"product_code":174,"device_name":175,"device_class":8,"k510_count":176},"FEB","Accessories, Cleaning, For Endoscope",57,{"product_code":178,"device_name":179,"device_class":8,"k510_count":180},"GCT","Light Source, Endoscope, Xenon Arc",47,{"product_code":182,"device_name":183,"device_class":8,"k510_count":184},"FDX","Endoscopic Cytology Brush",44,{"product_code":186,"device_name":187,"device_class":8,"k510_count":184},"ODG","Endoscopic Ultrasound System, Gastroenterology-Urology",{"product_code":189,"device_name":190,"device_class":8,"k510_count":191},"FBN","Choledochoscope And Accessories, Flexible\u002FRigid",43,{"product_code":193,"device_name":194,"device_class":8,"k510_count":191},"OCY","Endoscopic Guidewire, Gastroenterology-Urology",{"product_code":196,"device_name":197,"device_class":8,"k510_count":198},"LYK","Angioscope",41,{"product_code":200,"device_name":201,"device_class":8,"k510_count":202},"MPA","Endoilluminator",40,{"product_code":204,"device_name":205,"device_class":8,"k510_count":206},"FDT","Duodenoscope And Accessories, Flexible\u002FRigid",35,{"product_code":208,"device_name":209,"device_class":8,"k510_count":210},"FCW","Light Source, Fiberoptic, Routine",31,{"product_code":212,"device_name":213,"device_class":8,"k510_count":214},"FER","Anoscope And Accessories",27,{"product_code":216,"device_name":217,"device_class":8,"k510_count":214},"OCT","Anti Fog Solution And Accessories, Endoscopy",{"product_code":219,"device_name":220,"device_class":8,"k510_count":221},"FFS","Image, Illumination, Fiberoptic, For Endoscope ",26,{"product_code":223,"device_name":224,"device_class":8,"k510_count":225},"FCX","Insufflator, Automatic Carbon-Dioxide For Endoscope",25,{"product_code":227,"device_name":228,"device_class":8,"k510_count":229},"FAM","Sigmoidoscope And Accessories, Flexible\u002FRigid",24,{"product_code":231,"device_name":232,"device_class":8,"k510_count":229},"FJL","Resectoscope",{"product_code":234,"device_name":235,"device_class":8,"k510_count":236},"NLM","Laparoscope, General & Plastic Surgery, Reprocessed",23,{"product_code":238,"device_name":239,"device_class":8,"k510_count":240},"FEQ","Pump, Air, Non-Manual, For Endoscope",21,{"product_code":242,"device_name":243,"device_class":12,"k510_count":244},"FCO","Box, Battery, Rechargeable",20,{"product_code":246,"device_name":247,"device_class":8,"k510_count":244},"FDA","Enteroscope And Accessories",{"product_code":249,"device_name":250,"device_class":8,"k510_count":244},"ODE","Endoscopic Suture\u002FPlication System, Gastroesophageal Reflux Disease (Gerd)",{"product_code":252,"device_name":253,"device_class":8,"k510_count":254},"FBO","Cystourethroscope",19,{"product_code":256,"device_name":257,"device_class":8,"k510_count":258},"GCM","Endoscope, Rigid",18,{"product_code":260,"device_name":261,"device_class":8,"k510_count":258},"ODA","Endoscopic Central Control Unit",{"product_code":263,"device_name":264,"device_class":8,"k510_count":258},"ODD","Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula",{"product_code":266,"device_name":267,"device_class":8,"k510_count":268},"FHO","Pneumoperitoneum Needle",15,{"product_code":270,"device_name":271,"device_class":8,"k510_count":272},"GCI","Laryngoscope, Endoscope",14,{"product_code":274,"device_name":275,"device_class":8,"k510_count":276},"GCP","Endoscope, Ac-Powered And Accessories",13,{"product_code":278,"device_name":279,"device_class":8,"k510_count":280},"NVE","Washer, Cleaner, Automated, Endoscope",12,{"product_code":282,"device_name":283,"device_class":8,"k510_count":280},"ODF","Mini Endoscope, Gastroenterology-Urology",{"product_code":285,"device_name":286,"device_class":8,"k510_count":287},"FDC","Resectoscope, Working Element",11,{"product_code":289,"device_name":290,"device_class":8,"k510_count":287},"NZA","Accessories, Germicide, Cleaning, For Endoscopes",{"product_code":292,"device_name":293,"device_class":8,"k510_count":287},"OTJ","Laparoscopic Single Port Access Device",{"product_code":295,"device_name":296,"device_class":8,"k510_count":297},"FGA","Kit, Nephroscope",10,{"product_code":299,"device_name":300,"device_class":8,"k510_count":297},"OCV","Endoscope Holder",{"product_code":302,"device_name":303,"device_class":8,"k510_count":304},"GCS","Endoscope, Battery-Powered And Accessories",9,{"product_code":306,"device_name":307,"device_class":8,"k510_count":304},"NTN","Led Light Source",{"product_code":309,"device_name":310,"device_class":8,"k510_count":304},"NWB","Endoscope, Accessories, Narrow Band Spectrum",{"product_code":312,"device_name":313,"device_class":8,"k510_count":304},"PEA","Endoscope, Accessories, Image Post-Processing For Color Enhancement",{"product_code":315,"device_name":316,"device_class":8,"k510_count":304},"PLL","Submucosal Injection Agent",{"product_code":318,"device_name":319,"device_class":8,"k510_count":320},"QSM","System, Surgical, Computer Controlled Instrument, Remanufactured",8,{"product_code":322,"device_name":323,"device_class":8,"k510_count":324},"GDB","Endoscope, Fiber Optic",7,{"product_code":326,"device_name":327,"device_class":8,"k510_count":34},"FHX","Jelly, Lubricating, For Transurethral Surgical Instrument",{"product_code":329,"device_name":330,"device_class":12,"k510_count":34},"MNK","Endoscopic Bite Block",{"product_code":332,"device_name":333,"device_class":8,"k510_count":34},"OCU","Endoscopic Storage Cover",{"product_code":335,"device_name":336,"device_class":8,"k510_count":337},"FBP","Telescope, Rigid, Endoscopic",5,{"product_code":339,"device_name":340,"device_class":8,"k510_count":337},"GCQ","Endoscope, Flexible",{"product_code":342,"device_name":343,"device_class":8,"k510_count":337},"ODB","Endoscopic Contamination Prevention Sheath",{"product_code":345,"device_name":346,"device_class":8,"k510_count":347},"FDE","Laparoscopy Kit",4,{"product_code":349,"device_name":350,"device_class":12,"k510_count":347},"FEM","Accessories, Photographic, For Endoscope (Exclude Light Sources)",{"product_code":352,"device_name":353,"device_class":8,"k510_count":347},"FGS","Carrier, Sponge, Endoscopic",{"product_code":355,"device_name":356,"device_class":8,"k510_count":347},"GCL","Esophagoscope, General & Plastic Surgery",{"product_code":358,"device_name":359,"device_class":12,"k510_count":347},"MNL","Accessories, Cleaning Brushes, For Endoscope",{"product_code":361,"device_name":362,"device_class":8,"k510_count":347},"QZB","Software Controlled Endoscope And Instrument Holder",{"product_code":364,"device_name":365,"device_class":8,"k510_count":366},"FCC","Endoscopic Magnetic Retriever",3,{"product_code":368,"device_name":369,"device_class":8,"k510_count":366},"FCR","Light Source, Photographic, Fiberoptic",{"product_code":371,"device_name":372,"device_class":12,"k510_count":366},"FCY","Bulb, Inflation, For Endoscope",{"product_code":374,"device_name":375,"device_class":8,"k510_count":366},"FEC","Obturator, For Endoscope",{"product_code":377,"device_name":378,"device_class":8,"k510_count":366},"FFZ","Cord, Electric, For Endoscope",{"product_code":380,"device_name":381,"device_class":8,"k510_count":366},"FGC","Urethroscope",{"product_code":383,"device_name":384,"device_class":8,"k510_count":366},"GCO","Endoscope, Mirror",{"product_code":386,"device_name":387,"device_class":8,"k510_count":366},"NWU","Endoscope Introducer Kit",{"product_code":389,"device_name":390,"device_class":8,"k510_count":391},"FAK","Panendoscope (Gastroduodenoscope)",2,{"product_code":393,"device_name":394,"device_class":8,"k510_count":391},"FAN","Sigmoidoscope, Rigid, Electrical",{"product_code":396,"device_name":397,"device_class":12,"k510_count":391},"FCP","Box, Battery, Pocket",{"product_code":399,"device_name":400,"device_class":12,"k510_count":391},"FDZ","Attachment, Eyepiece, For Insertion Of Prescription Lens",{"product_code":402,"device_name":403,"device_class":12,"k510_count":391},"FEA","Attachment, Teaching, For Endoscope",{"product_code":405,"device_name":406,"device_class":12,"k510_count":391},"FEI","Instrument, Special Lens, For Endoscope",{"product_code":408,"device_name":409,"device_class":12,"k510_count":391},"FFY","Adaptor, Bulbs, Miscellaneous, For Endoscope",{"product_code":411,"device_name":412,"device_class":8,"k510_count":391},"FHP","Needle, Pneumoperitoneum, Simple",{"product_code":414,"device_name":415,"device_class":8,"k510_count":391},"FTI","Lamp, Endoscope, Incandescent",{"product_code":417,"device_name":418,"device_class":8,"k510_count":391},"GCF","Proctoscope",{"product_code":420,"device_name":421,"device_class":8,"k510_count":391},"KGD","Scissors For Cystoscope",{"product_code":423,"device_name":424,"device_class":8,"k510_count":391},"NBG","Marker, Colon",{"product_code":426,"device_name":427,"device_class":8,"k510_count":391},"NEQ","Device, Telemedicine, Robotic",{"product_code":429,"device_name":430,"device_class":8,"k510_count":391},"PCV","Endoscopic Leak Tester",{"product_code":432,"device_name":433,"device_class":8,"k510_count":391},"SFE","Endoscopic Video Imaging System \u002F Software Component For Real Time Video Augmentation",{"product_code":435,"device_name":436,"device_class":8,"k510_count":33},"FAL","Panendoscope (Urethroscope)",{"product_code":438,"device_name":439,"device_class":8,"k510_count":33},"FCQ","Light Source, Incandescent, Diagnostic",{"product_code":441,"device_name":442,"device_class":8,"k510_count":33},"FDP","Apparatus, Pneumoperitoneum, Automatic",{"product_code":444,"device_name":445,"device_class":12,"k510_count":33},"FEJ","Attachment, Binocular, For Endoscope",{"product_code":447,"device_name":448,"device_class":8,"k510_count":33},"GCW","Transformer, Endoscope",{"product_code":450,"device_name":451,"device_class":8,"k510_count":33},"KDM","Sigmoidoscope, Rigid, Non-Electrical",{"product_code":453,"device_name":454,"device_class":8,"k510_count":33},"KDO","Rongeur, Cystoscopic, Hot",{"product_code":456,"device_name":457,"device_class":8,"k510_count":33},"KYH","Endoscope, Ophthalmic",{"product_code":459,"device_name":460,"device_class":8,"k510_count":33},"MFJ","Device, Endoscopic Suturing",{"product_code":462,"device_name":463,"device_class":8,"k510_count":33},"NWS","Kit, Choledochoscope, Flexible And Rigid",{"product_code":465,"device_name":139,"device_class":8,"k510_count":33},"OCS",{"product_code":467,"device_name":468,"device_class":8,"k510_count":33},"PUP","Endoscope Maintenance System",{"product_code":470,"device_name":471,"device_class":8,"k510_count":33},"QGY","Mobile \u002F Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera",{"product_code":473,"device_name":474,"device_class":8,"k510_count":33},"SHU","Appendiceal Scope And Accessories, Flexible",{"product_code":476,"device_name":477,"device_class":12,"k510_count":31},"EXZ","Equipment, Photographic, For Physiologic Function Monitor",{"product_code":479,"device_name":480,"device_class":8,"k510_count":31},"FBI","Rongeur, Cystoscopic",{"product_code":482,"device_name":483,"device_class":12,"k510_count":31},"FCZ","Tube, Smoke Removal, Endoscopic",{"product_code":485,"device_name":486,"device_class":8,"k510_count":31},"FDR","Sphyncteroscope",{"product_code":488,"device_name":489,"device_class":8,"k510_count":31},"FDW","Esophagoscope, Rigid, Gastro-Urology",{"product_code":491,"device_name":492,"device_class":12,"k510_count":31},"FDY","Device, Measuring, For Panendoscope",{"product_code":494,"device_name":495,"device_class":8,"k510_count":31},"FTJ","Colonoscope, General & Plastic Surgery",{"product_code":497,"device_name":498,"device_class":8,"k510_count":31},"GCG","Peritoneoscope",{"product_code":500,"device_name":501,"device_class":8,"k510_count":31},"GCH","Mediastinoscope, Diagnostic",{"product_code":503,"device_name":504,"device_class":8,"k510_count":31},"GCK","Gastroscope, General & Plastic Surgery",{"product_code":506,"device_name":507,"device_class":8,"k510_count":31},"GCN","Endoscope, Prism",{"product_code":509,"device_name":510,"device_class":8,"k510_count":31},"NKZ","Endoilluminator, Reprocessed",{"product_code":512,"device_name":513,"device_class":8,"k510_count":31},"NLX","Needle, Pneumoperitoneum, Spring Loaded, Reprocessed",{"product_code":515,"device_name":516,"device_class":8,"k510_count":31},"NMY","Needle, Endoscopic, Reprocessed",{"product_code":518,"device_name":519,"device_class":8,"k510_count":31},"NWT","Endoscopic Cholangiogram Kit",{"product_code":521,"device_name":522,"device_class":12,"k510_count":31},"PHT","Basin For Endoscope Reprocessing",{"product_code":524,"device_name":525,"device_class":8,"k510_count":31},"PPE","Nephroscope Set",{"product_code":527,"device_name":528,"device_class":8,"k510_count":31},"PTQ","Endoscopic Magnetic Retriever, Exempt",{"product_code":530,"device_name":531,"device_class":8,"k510_count":31},"PTR","Scissors For Cytoscope, Exempt",{"product_code":533,"device_name":534,"device_class":8,"k510_count":31},"PTS","Endoscopic Grasping\u002FCutting Instrument, Non-Powered, Exempt",{"product_code":536,"device_name":537,"device_class":8,"k510_count":31},"SBX","Software For Endoscopy Procedure Metrics",{"510k":539,"classification":540,"enforcement":541,"event":542,"pma":543,"warning_letter":544},"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":546,"definition_ja":547,"commentary_ja":548,"model_name":549,"source_hash":550,"reviewed_by":32,"reviewed_at":32,"created_at":551,"updated_at":551},"内視鏡位置表示用空間イメージング装置","挿入された内視鏡の形状を検出し、表示するためのものである。","本品は米国においてクラスIIに分類されており、市販前届出（510(k)）の対象となる医療機器です。510(k)では、既に合法的に販売されている同等の機器（既存同等機器）との実質的同等性を示すことで、市販前承認（PMA）よりも簡易な手続きで市場投入が可能です。","claude-sonnet-5","9cc400f2c24b16dc99cc19df6e978a2940503ae79ed83371018f44020c12bd91","2026-08-24T02:30:13.381035+00:00",{"product_code":6,"summary_ja":553,"stats":554,"stats_hash":567,"model_name":549,"created_at":568,"updated_at":568},"本製品コードは510(k)による市販前届出の対象で、累計届出件数は1件、参入企業数は1社、直近5年間の届出はありません。最新の判定は2014年3月です。不具合報告は累計約6件で、その大半が不具合（Malfunction）であり、傷害報告が1件含まれています。主な問題として、部品の不良（Defective Component）、機器の不良（Defective Device）、接続の緩みまたは断続的な接続不良（Loose or Intermittent Connection）が挙げられています。回収については累計0件で、クラスI以上の回収は確認されていません。",{"pma":555,"k510":556,"as_of":558,"events":559,"recalls":561,"top_problems":563},{"latest":32,"originals":31,"supplements":31},{"total":33,"last5y":31,"latest":557,"applicants":33},"2014-03-07","2026-08",{"death":31,"other":31,"total":34,"injury":33,"last5y":337,"malfunction":337,"latest_month":560},"2026-07",{"total":31,"last5y":31,"latest":32,"class_i":31,"class_ii":31,"class_iii":31,"top_root_causes":562},[],[564,565,566],"Defective Component","Defective Device","Loose or Intermittent Connection","a1a6259f96e21c471c60448202514529de3fa0c95b9b04dcb40931641d8188c8","2026-08-24T05:09:58.149854+00:00",{"items":570,"total":31},[],{"items":572,"total":33},[573],{"k_number":18,"device_name":574,"applicant":575,"decision_date":557,"clearance_type":576,"decision_code":577,"statement_or_summary":578},"ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT","Olympus Medical Systems Corp.","Traditional","SESE","Summary",{"items":580,"total":31},[]]