# K131977: Centricity Universal Viewer Zero Footprint Client

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 17, 2013 after 81 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K942120 (1994). 14 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123174: Centricity Pacs-IW with Universal Viewer, GE Healthcare (2012) Summary page 1.

## Most influential descendants
- K141881: Rapidresults (2014), 5 descendants of its own
- K222476: OmegaAI Image Viewer (2022), 3 descendants of its own
- K254237: Cci Pacs Viewer (Pacs-US-001) (2026), 0 descendants of its own
- K241546: aiCockpit AI Viewer (2025), 0 descendants of its own
- K242362: Lightning Viewer (2024), 0 descendants of its own

## Recalls of this device
- Jan 16, 2026 · Class II · Z-1475-2026: Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.
- Oct 3, 2024 · Class II · Z-0318-2025: GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security vulnerability which could allow a malicious actor to access th
- Aug 29, 2024 · Class II · Z-0039-2025: GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occ
- Jul 23, 2024 · Class II · Z-3160-2024: Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the origina
- Jun 8, 2022 · Class II · Z-1333-2022: Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)
- Apr 28, 2022 · Class II · Z-1229-2022: 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 mea
- Oct 15, 2021 · Class II · Z-0329-2022: There is a potential to display incomplete patient imaging study.
- Nov 9, 2018 · Class II · Z-0641-2019: Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and vertically, the orientation markers appear correctly

## Indications for use
Centricity Universal Viewer Zero Footprint client is a device that displays medical images, data from various imaging sources, and other healthcare information sources. Medical images and data can be viewed, communicated, processed and displayed within a computer network or on a workstation. The device may be used to provide images for diagnostic purposes by trained professionals. Typical users of this system are authorized individuals and trained healthcare professionals who view medical images and data. Mammographic images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Contraindications: Centricity Universal Viewer Zero Footprint client is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Source page: https://510kreport.com/device/K131977
Methodology: https://510kreport.com/methodology