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ViewFinder Software Version 1.1

by Elaitra, Ltd.

510(k) K223501

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 NumberK223501 Date21 Apr 2023ClearedStatusActive

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  • Withdrawn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
QIH
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.

ViewFinder Software Version 1.1 is a medical device software designed for radiology applications. It serves as a tool for radiologists to view and analyze medical images.

The software is supplied by Elaitra, Ltd. and has received FDA 510(k) clearance with product code QIH. It is intended for use in radiology settings and is regulated as a substantially equivalent device.

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 the ViewFinder Software Version 1.1 used for?

    ViewFinder Software Version 1.1 is a medical device software designed specifically for radiology applications. It serves as a tool for radiologists to view and analyze medical images, providing functionality tailored to radiology settings.

  • How is the ViewFinder Software Version 1.1 supplied?

    The software is supplied by Elaitra, Ltd., a company based in London. It is distributed as a medical device software product intended for use in radiology departments and healthcare facilities that require image analysis capabilities.

  • What is the regulatory status of ViewFinder Software Version 1.1?

    ViewFinder Software Version 1.1 has received FDA 510(k) clearance with product code QIH. It is regulated as a substantially equivalent device, meaning it has been determined to be as safe and effective as a legally marketed device that is not new or different.

  • What are the technical specifications of ViewFinder Software Version 1.1?

    The device is a software application designed for radiology image viewing and analysis. While specific technical details beyond its core functionality are not provided in the available data, it is intended to support radiologists in their image interpretation workflow.