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Visage PACS/CS, Release Version 5.0

by Mercury Computer Systems, Inc.

510(k) K072205

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 · Special NumberK072205 Date29 Aug 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  • Withdrawn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, 26 Sep 2026

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

Visage PACS/CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities. It integrates with other hospital information systems including HIS, RIS, and CIS via special interfaces. This system is classified as a Class II X-ray system and is designed for radiology applications.

The device is manufactured by Mercury Computer Systems, Inc. and has received FDA 510(k) clearance with product code LLZ. It was first cleared in 2006 and most recently cleared in 2007. The system is intended for use in radiology settings and is regulated under 892.2050 Classification name System, Image Processing, Radiological.

Other devices from Mercury Computer Systems, Inc.

Questions

AI-generated answers, 26 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 Visage PACS/CS used for?

    Visage PACS/CS is designed for radiology applications, integrating with hospital information systems to distribute 3D image data.

  • Is Visage PACS/CS cleared for use in the US?

    Yes, Visage PACS/CS has received FDA 510(k) clearance, indicating it is substantially equivalent to a predicate device.

  • What type of system is Visage PACS/CS classified as?

    Visage PACS/CS is classified as a Class II X-ray system, regulated under 892.2050 Classification name System, Image Processing, Radiological.