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510(k) K122470

PENTAX EPK-I5010 VIDEO PROCESSOR by Pentax Medical — Product Code PEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2013
Date Received
August 13, 2012
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.

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  • K093037 — PENTEX EC-3890LI (December 28, 2009)

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