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Centricity Pacs Iw

by Ge Healthcare Dynamic Imaging Solutions

510(k) K082318

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 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 · Special NumberK082318 Date25 Aug 2008ClearedStatusActive

Recalls

7 recalls · 2 ongoing · FDA

    • Ongoing Z-0138-2024 FDA Class II initiated 14 Sep 2023

    GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.

    • Ongoing Z-1502-2023 FDA Class II initiated 28 Mar 2023

    GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.

    • Terminated Z-1781-2019 FDA Class II initiated 22 May 2019

    There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.

    • Terminated Z-1302-2018 FDA Class II initiated 23 Feb 2018

    A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or more image series (i.e. all images within an image set) may be missing from an exam without indication to the user. While this is rare, this can occur with imaging studies that consist of a very small number of images per series. E.g. CR Thorax exam with 1 image per series.

    • Terminated Z-0023-2016 FDA Class II initiated 16 Sep 2015

    Images may be missing when a system parameter MapRoute is set to a value greater than 1.

    • Terminated Z-1394-2010 FDA Unclassified (pre-2012) initiated 18 Feb 2010

    There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software related to use of built-in reconstruction functions which may result in incorrect anatomic orientation markers.

    • Terminated Z-1402-2010 FDA Unclassified (pre-2012) initiated 11 Feb 2010

    There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software when dragging-and-dropping images from the Navigator causing flipping of the images that may impact patient safety.

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

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