# K123174: Centricity Pacs-IW with Universal Viewer

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Nov 16, 2012 after 37 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K942120 (1994). 13 ancestors in all.
15 later devices descend from it; 6 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121387: Centricity Pacs-IW, Ge Healthcare Integrated IT Solutions (2012) Summary page 1.

## Most influential descendants
- K131977: Centricity Universal Viewer Zero Footprint Client (2013), 6 descendants of its own
- K141881: Rapidresults (2014), 5 descendants of its own
- K222476: OmegaAI Image Viewer (2022), 3 descendants of its own
- K150420: Centricity Universal Viewer (2015), 3 descendants of its own
- K182419: Centricity Universal Viewer (2018), 2 descendants of its own

## Recalls of this device
- Jan 30, 2026 · Class II · Z-1571-2026: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an 
- Feb 19, 2025 · Class II · Z-1484-2025: 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 ser
- Sep 14, 2023 · Class II · Z-0139-2024: 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 View
- Mar 28, 2023 · Class II · Z-1500-2023: GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
- Oct 28, 2022 · Class II · Z-0721-2023: There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can re
- Aug 6, 2021 · Class II · Z-2502-2021: Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
- May 17, 2019 · Class II · Z-1885-2019: There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
- Oct 11, 2018 · Class II · Z-0374-2019: Synchronization failure
- Jan 25, 2018 · Class II · Z-2101-2018: Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
- Sep 28, 2015 · Class II · Z-0225-2016: Inaccurate distance measurements with magnified projection X-ray images.

## Indications for use
Centricity PACS-IW with Universal Viewer is a software only product that is part of a Picture Archiving and Communication System (PACS) medical device. Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

Source page: https://510kreport.com/device/K123174
Methodology: https://510kreport.com/methodology