Centricity Pacs Web Diagnostic

510(k) K083018

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK083018	Date14 Nov 2008Cleared	StatusActive

4 recalls · FDA

- Terminated Z-1782-2017 FDA Class II initiated 18 Feb 2013
It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.
- Terminated Z-0118-2014 FDA Class II initiated 15 Jun 2012
Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixe
- Terminated Z-1395-2010 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-1403-2010 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.

1 jurisdiction

United States — FDA 510(k) Active

510(k)