Endoscope, Accessories, Image Post-processing For Color Enhancement
Gastroenterology, Urology · 21 CFR 876.1500
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
Recent MDR events
608 adverse event reports on file
- PENTAXJul 27, 2026MalfunctionHoya Corporation Pentax Tokyo Office9610877-2026-51527
- PENTAXJul 27, 2026MalfunctionHoya Corporation Pentax Tokyo Office9610877-2026-51524
- PENTAXJul 22, 2026MalfunctionHoya Corporation Pentax Tokyo Office9610877-2026-00038
- PENTAXJul 22, 2026MalfunctionHoya Corporation Pentax Tokyo Office9610877-2026-00039
- PENTAXJun 18, 2026MalfunctionHoya Corporation Pentax Tokyo Office9610877-2026-00030
- PENTAXJun 16, 2026InjuryHoya Corporation Pentax Tokyo Office2518897-2026-00009
- PENTAXJun 16, 2026InjuryHoya Corporation Pentax Tokyo Office9610877-2026-00033
- PENTAXJun 5, 2026MalfunctionHoya Corporation Pentax Tokyo Office9610877-2026-51225
- PENTAXMay 21, 2026MalfunctionHoya Corporation Pentax Tokyo Office9610877-2026-51138
- PENTAXMay 1, 2026MalfunctionHoya Corporation Pentax Tokyo Office9610877-2026-00023
Event type breakdown
Recalls
4 recall events for this product code
- Pentax of America IncOpen, ClassifiedAug 15, 2025
Pentax Medical Video Processor;
During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.
Z-2329-2025 · View FDA record ↗ - Pentax of America IncOpen, ClassifiedFeb 26, 2025
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal trac
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
Z-1236-2025 · View FDA record ↗ - Pentax of America IncOpen, ClassifiedFeb 26, 2025
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tra
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
Z-1237-2025 · View FDA record ↗ - Pentax of America IncOpen, ClassifiedFeb 26, 2025
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, a
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
Z-1238-2025 · View FDA record ↗
Registered firms
44 firms currently registered for this product code
Medical Resale Pty Limited
Caloundra QLD Queensland, AU
Plexus Manufacturing Sdn .bhd.
Bayan Lepas Pulau Pinang, MY
Hoya Corporation Pentax Lifecare Division
Akishima-shi Tokyo, JP
Yoshikawa Kasei Co., Ltd. Medical Company Shizuoka Plant
Fukuroi City Shizuoka, JP
Hoya Corporation Pentax Lifecare Division
KURIHARA-SHI Miyagi, JP
Pentax Medical (penang) Sdn. Bhd.
Penang Pulau Pinang, MY
Fujifilm Healthcare Manufacturing Corporation Sano Office
Sano City Tochigi, JP
Fujifilm Corporation Medical Systems Research & Development Center Kaisei
Ashigarakami-Gun Kanagawa, JP
510(k) clearances
9 clearances for this product code
- Pentax of America, Inc.Jun 3, 2025
K251127 · PENTAX Medical Video Processor (EPK-i8020c)
- Pentax of America, Inc.Jul 28, 2023
K231249 · PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
- Pentax of America, Inc.Dec 20, 2019
K190805 · PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL
- Pentax of America, Inc.Nov 8, 2019
K191282 · PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
- Pentax of America, Inc.Jul 3, 2018
K173679 · PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
- Endochoice, Inc.Aug 1, 2016
K160275 · Fuse Endoscopic System with FuseBox Processor
- Pentax of America, Inc.Nov 24, 2015
K150618 · PENTAX Medical EPK-i7010 Video Processor with GI Family
- Fujifilm Medical Systems U.S.A, Inc.Aug 22, 2014
K140149 · EPX-4440HD DIGITAL VIDEO PROCESSOR