510(k) Report

Devices descending from K102466

37 later devices reach Fujinon Epx-4440HD Digital Video Processor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140149Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc.201416—
+1K131953IMAGE1 SpiesKARL STORZ Endoscopy-America, Inc.2013101
+1K113873Pentax Epk-I5020 Video ProcessorPentax of America, Inc.20127—
+1K111997IMAGE1 GI Ccu Model 22203020-114KARL STORZ Endoscopy-America, Inc.20120—
+2K221781Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KHGuangdong Optomedic Technologies, Inc.20230—
+2K190648Pusen Eview Medical Video Endoscope Image ProcessorZhuhai Pusen Medical Technology Co., Ltd.20191—
+2K180414EPX-4440FN Digital Video Processor with Light SourceFujifilm New Development U.S.A., Inc.20180—
+2K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc.201712—
+2K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc.20178—
+2K160044Image1 SPIES SystemKarl Storz Endoscopy America, Inc.20166—
+2K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc.20150—
+2K122470Pentax Epk-I5010 Video ProcessorPentax Medical20136—
+3K251734ProVee Video Processing Unit (PV-003)Proverum Limited20250—
+3K250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.20250—
+3K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation20250—
+3K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+3K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base…Iq Endoscopes Limited20230—
+3K201135Image1 S CCU, Image1 S 4U Camera HeadKARL STORZ Endoscopy-America, Inc.20204—
+3K192286FUJIFILM EP-6000 Video ProcessorFujifilm Corporation20200—
+3K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation20206—
+3K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.20191—
+3K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc.201901
+3K150618PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc.20153—
+4K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+4K250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private Limited20250—
+4K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.20230—
+4K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+4K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.202314
+4K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+4K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+5K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+5K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+5K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+5K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.202501
+5K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+5K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+6K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC20260—