# K110875: Centricity Pacs

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: May 5, 2011 after 36 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: 5 generations back to K913770 (1991). 9 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043415: Centricity Pacs System, Ge Medical Systems Information Technologies (2005) Summary page 1.

## Most influential descendants
- K133508: Resolutionmd Mobile (2014), 5 descendants of its own
- K161130: ResolutionMD (2016), 4 descendants of its own
- K260500: ResolutionMD (2026), 0 descendants of its own
- K183248: Synapse Enterprise Viewer Version 1.0 (2019), 0 descendants of its own
- K181185: Change Healthcare Enterprise Viewer (2018), 0 descendants of its own

## Recalls of this device
- Jul 31, 2026 · Class II · Z-3171-2026: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the 
- Jul 31, 2026 · Class II · Z-3166-2026: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the 
- Jul 31, 2026 · Class II · Z-3169-2026: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the 
- Jul 31, 2026 · Class II · Z-3167-2026: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the 
- Jul 31, 2026 · Class II · Z-3170-2026: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the 
- Jul 31, 2026 · Class II · Z-3168-2026: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the 
- Aug 5, 2024 · Class II · Z-3214-2024: GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acq
- Jun 14, 2022 · Class II · Z-1466-2022: The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
- Apr 28, 2022 · Class II · Z-1233-2022: 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
- May 16, 2019 · Class II · Z-1911-2019: There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.

## Indications for use
The Centricity PACS provides scalable image and data management solutions for medical imaging modalities, such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), Oral X-Ray (10), Endoscopic Video (ES), and any other DICOM devices. The workstation interface software provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure. To be viewed for primary interpretation, the digital mammography images must be acquired from an FDA approved Full Field Digital Mammography (FFOM) device for primary interpretation. Furthermore, the FFDM must be able to provide, to the Centricity PACS, a viewable DICOM 'for presentation' mammography image as approved by the FDA for primary interpretation. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images. To be viewed for primary diagnosis, digital mammography images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The Centricity PACS allows integration with other open interfaces, such as DICOM, to web client products and archive devices. The Centricity Infrastructure software provides for the system's database and image management, printing, HL-7 interfacing, and all DICOM services including but not limited to, Store, Print, Query/Retrieve, and Send. It is the users responsibility to ensure quality, ambient light conditions, and image compression ratios are consistent with the clinical application.

Source page: https://510kreport.com/device/K110875
Methodology: https://510kreport.com/methodology