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Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy

by Ge Healthcare Integrated IT Solutions

510(k) K063628

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

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 NumberK063628 Date26 Dec 2006ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1486-2025 FDA Class II initiated 19 Feb 2025
    • Ongoing Z-1485-2025 FDA Class II initiated 19 Feb 2025

    There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

    • Ongoing Z-1231-2022 FDA Class II initiated 28 Apr 2022

    Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.

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  • Withdrawn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, 6 Oct 2026

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

Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy is a medical information system designed to interface with various healthcare environments. It functions by integrating with information systems such as the hospital information system, radiology information system, and cardiovascular information system.

This system may be supplied as software only or as a turnkey system. It has received FDA 510K authorization under the traditional clearance process. The device is categorized under the radiology advisory committee.

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