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Pentax Medical EPK-3000 Video Imaging System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182846

by PENTAX of America, Inc.

Identifiers

510(k) Number
K182846 FDA 510(k)
FDA Product Code
EOB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.4760 FDA 510(k)
Regulation Number
874.4760 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pentax Medical EPK-3000 Video Imaging System is a nasopharyngoscope video imaging system designed to capture optical images of upper airway anatomy. It functions by utilizing a distal-end image sensor and a 150W xenon lamp for illumination.

The system consists of a video processor, VNL-J10 series flexible naso-pharyngo-laryngoscopes, digital video capture modules, and a laryngeal strobe. This device is authorized under FDA 510(k) clearance K182846.

Frequently asked questions

What is the primary function of the PENTAX Medical EPK-3000?

This system is designed to capture optical images of the upper airway anatomy. It achieves this by utilizing a distal-end image sensor combined with a 150W xenon lamp to provide the necessary illumination for visualization.

What components are included in the EPK-3000 system?

The system is a comprehensive imaging suite that includes a video processor, VNL-J10 series flexible naso-pharyngo-laryngoscopes, digital video capture modules, and a laryngeal strobe to facilitate clinical imaging.

What is the regulatory status of this device?

The PENTAX Medical EPK-3000 Video Imaging System is authorized under FDA 510(k) clearance K182846, which indicates it has been found substantially equivalent to other legally marketed devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PENTAX Medical EPK-3000 Video Imaging System (K172156) — FDA 510 (k ..., PDF PENTAX of America, Inc. William Goeller Vice President, Quality and ..., PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
PENTAX of America, Inc.

Sources (1)

  • FDA 510(k) K182846 24 fields · synced Sep 22, 2026