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510(k) 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 by Pentax of America, Inc. — Product Code PEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2019
Date Received
March 29, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Accessories, Image Post-Processing For Color Enhancement
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.

Other clearances by Pentax of America, Inc.

  • K251256 — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Vid (December 16, 2025)
  • K251127 — PENTAX Medical Video Processor (EPK-i8020c) (June 3, 2025)
  • K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL) (January 3, 2025)
  • K241213 — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscop (December 6, 2024)
  • K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (August 1, 2024)
  • K240457 — C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) (July 24, 2024)
  • K232860 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB1 (January 18, 2024)
  • K231970 — PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use (January 12, 2024)
  • K232249 — PENTAX Medical Gas/Water Feeding Valve OE-B14 (December 1, 2023)
  • K231249 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope E (July 28, 2023)

Other clearances for product code PEA

  • K251127 — PENTAX Medical Video Processor (EPK-i8020c) (June 3, 2025)
  • K231249 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope E (July 28, 2023)
  • K191282 — PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family (November 8, 2019)
  • K173679 — PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (July 3, 2018)
  • K160275 — Fuse Endoscopic System with FuseBox Processor (August 1, 2016)
  • K150618 — PENTAX Medical EPK-i7010 Video Processor with GI Family (November 24, 2015)
  • K140149 — EPX-4440HD DIGITAL VIDEO PROCESSOR (August 22, 2014)
  • K122470 — PENTAX EPK-I5010 VIDEO PROCESSOR (April 10, 2013)