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Visio+cd Viewer# KPSCDVE01

by Keosys Sas

510(k) K070606

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 NumberK070606 Date24 Apr 2007ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

The Visio+ CD Viewer KPSCDVE01 is a DICOM-compatible image review and manipulation software designed for radiology applications. Classified as a Class II X-ray system, it functions as a standalone viewer for medical imaging data distributed on CD-ROMs, enabling clinicians to assess and manipulate diagnostic images without additional hardware dependencies.

This software is intended for use by trained professionals, including physicians and radiologists, on standard Windows-based PCs meeting minimum specifications (Pentium III, 1 GHz processor, 512 MB RAM). Supplied as a single-use CD-ROM, it requires no sterilisation or regulatory classification beyond its FDA 510(k) clearance under K-number K070606, granted in 2007. No MRI safety or reusable components are specified.

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