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ViewMate Ultrasound Imaging System

by Ep Medsystems 510(k)

Active United States

510(k) K031066

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031066 Date17 Oct 2003ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ViewMate Ultrasound Imaging System is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. It is designed to be used in a hospital or medical setting.

The system received FDA 510(k) clearance under K031066 with a decision date of 2003-10-17 and is classified under product code IYN. It was reviewed by the Radiology advisory committee and determined to be substantially equivalent through a traditional 510(k) pathway.

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