FDA.reportPublic FDA data

510(k) K251127

Device
PENTAX Medical Video Processor (EPK-i8020c)
Applicant
Pentax of America, Inc.
510(k) number
K251127
Product code
PEA
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-03
Date received
2025-04-11
Regulation
876.1500
Classification name
Endoscope, Accessories, Image Post-Processing For Color Enhancement
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Gurvinder Singh Nanda
Address
3 Paragon Dr., Montvale NJ US 07645 07645

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PEA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cLPentax of America, Inc.2023-07-28
K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cLPentax of America, Inc.2019-12-20
K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc.2019-11-08
K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, Inc.2018-07-03
K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.2016-08-01
K150618PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc.2015-11-24
K140149EPX-4440HD DIGITAL VIDEO PROCESSORFujifilm Medical Systems U.S.A, Inc.2014-08-22
K122470PENTAX EPK-I5010 VIDEO PROCESSORPentax Medical2013-04-10