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EUNITY

by Client Outlook, Inc. 3 variants

510(k) K111164

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111164 Date6 May 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

EUNITY is a server-based software solution that extends common web-browsers on the most popular operating systems into medical review stations. It is designed to load, display and manipulate medical (DICOM) images within a web-browser without installing client software.

The device is a Class 2 Radiology device with product code LLZ, cleared through the Traditional 510(k) pathway by the FDA. It received FDA 510(k) clearance under K-number K111164 on May 6, 2011, and is manufactured by Client Outlook, Inc. in Waterloo, Ontario, Canada.

Other devices from Client Outlook, Inc.

  • eUnity

    Class II

  • eUnity

    Class II

Questions

AI-generated answers, 23 Sep 2026

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

  • What is EUNITY used for?

    EUNITY is designed to load, display and manipulate medical DICOM images within a web-browser without installing client software, extending common web-browsers on popular operating systems into medical review stations for radiology use.

  • How is EUNITY supplied and accessed?

    EUNITY is a server-based software solution that runs on a server and is accessed through standard web-browsers on common operating systems, requiring no client-side software installation for users to view and manipulate medical images.

  • Is EUNITY a single-use or reusable device?

    EUNITY is a reusable software solution; as a server-based application, it supports multiple users and sessions over time, with no physical components that are consumed or discarded after a single use.

  • What regulatory pathway was used for EUNITY's clearance?

    EUNITY received FDA 510(k) clearance through the Traditional 510(k) pathway under K-number K111164, with a decision of substantially equivalent to a predicate device, and is classified as a Class 2 Radiology device with product code LLZ.