510(k) · Cleared
Recalled · Class II · 2026Centricity Pacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · LLZ System, Image Processing, Radiological
Cleared on May 5, 2011 as substantially equivalent to K043415 (Ge Medical Systems Information Technologies, 2005) after a 36-day review. Its family tree reaches back 5 generations to 1991. 6 later devices descend from it. It has been recalled 10 times.
- Decided
- May 5, 2011
- Review
- 36 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 10
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913770 (1991). 9 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 2 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 1 generation backK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- This deviceK110875 Centricity PacsGE Healthcare · 2011
- Descendant · cites it directly · 5 of its ownK133508 Resolutionmd MobileCalgary Scientific, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK161130 ResolutionMDCalgary Scientific, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK260500 ResolutionMDResolutionMD, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK183248 Synapse Enterprise Viewer Version 1.0Fujifilm Corporation · 2019
- Descendant · 3 generations on · 0 of its ownK181185 Change Healthcare Enterprise ViewerChange Healthcare Canada Company · 2018 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133508Resolutionmd MobileCalgary Scientific, Inc. · 2014 · cites it directly5descendants
- K161130ResolutionMDCalgary Scientific, Inc. · 2016 · 2 generations on4descendants
- K260500ResolutionMDResolutionMD, Inc. · 2026 · 3 generations on0descendants
- K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation · 2019 · 3 generations on0descendants
- K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −3 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −2 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −1 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| 0 (this device) | K110875 | Centricity Pacs | GE Healthcare | 2011 | — |
| +1 | K133508 | Resolutionmd Mobile | Calgary Scientific, Inc. | 2014 | — |
| +2 | K161130 | ResolutionMD | Calgary Scientific, Inc. | 2016 | — |
| +3 | K260500 | ResolutionMD | ResolutionMD, Inc. | 2026 | — |
| +3 | K183248 | Synapse Enterprise Viewer Version 1.0 | Fujifilm Corporation | 2019 | — |
| +3 | K181185 | Change Healthcare Enterprise Viewer | Change Healthcare Canada Company | 2018 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043415 | Centricity Pacs SystemSummary page 1…logical Product Code: LLZ Secondary Product GCJ Code: 876.1500 Endoscope and accessories Predicate Devicels): K043415 CentricityTH PACS GE Healthcare - Confidential Centricity PACS Traditional 510(k… | 2005 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133508 | Resolutionmd Mobile | 2014 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2026 | Class II | Z-3171-2026 | Under Investigation by firm | 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 wrong patient record, which could lead… |
| Jul 31, 2026 | Class II | Z-3166-2026 | Under Investigation by firm | 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 wrong patient record, which could lead… |
| Jul 31, 2026 | Class II | Z-3169-2026 | Under Investigation by firm | 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 wrong patient record, which could lead… |
| Jul 31, 2026 | Class II | Z-3167-2026 | Under Investigation by firm | 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 wrong patient record, which could lead… |
| Jul 31, 2026 | Class II | Z-3170-2026 | Under Investigation by firm | 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 wrong patient record, which could lead… |
| Jul 31, 2026 | Class II | Z-3168-2026 | Under Investigation by firm | 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 wrong patient record, which could lead… |
| Aug 5, 2024 | Class II | Z-3214-2024 | Device Design | 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 acquisition of a partial study. |
| Jun 14, 2022 | Class II | Z-1466-2022 | Software design | 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 | Software design | 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 measurement values when performed on… |
| May 16, 2019 | Class II | Z-1911-2019 | Device Design | 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. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K133508 (Calgary Scientific, Inc., 2014) has gone furthest, with 5 descendants of its own.
- 10 other devices also cite its predicate K043415.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (252 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110875: Centricity Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110875
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026