510(k) · Cleared
Recalled · Class II · 2026Centricity Universal Viewer
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 26, 2015 as substantially equivalent to K123174 (GE Healthcare, 2012) after a 97-day review. Its family tree reaches back 7 generations to 1994. 3 later devices descend from it. It has been recalled 15 times.
- Decided
- May 26, 2015
- Review
- 97 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 15
- Predicates
- 1
Its longest line of descent runs back 7 generations to K942120 (1994). 14 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 6 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 5 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 4 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 3 generations backK082318 Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions · 2008 · Recalled
- 2 generations backK121387 Centricity Pacs-IWGe Healthcare Integrated IT Solutions · 2012 · Recalled
- 1 generation backK123174 Centricity Pacs-IW with Universal ViewerGE Healthcare · 2012 · Recalled
- This deviceK150420 Centricity Universal ViewerGE Healthcare · 2015
- Descendant · cites it directly · 2 of its ownK182419 Centricity Universal ViewerGE Healthcare · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK211312 Universal ViewerGE Healthcare · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK253639 ViewGE Healthcare · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −6 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −5 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −4 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −3 | K082318 | Centricity Pacs IW | Ge Healthcare Dynamic Imaging Solutions | 2008 | 7 |
| −2 | K121387 | Centricity Pacs-IW | Ge Healthcare Integrated IT Solutions | 2012 | 1 |
| −1 | K123174 | Centricity Pacs-IW with Universal Viewer | GE Healthcare | 2012 | 10 |
| 0 (this device) | K150420 | Centricity Universal Viewer | GE Healthcare | 2015 | — |
| +1 | K182419 | Centricity Universal Viewer | GE Healthcare | 2018 | 8 |
| +2 | K211312 | Universal Viewer | GE Healthcare | 2021 | 2 |
| +3 | K253639 | View | GE Healthcare | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K123174 | Centricity Pacs-IW with Universal ViewerSummary page 4…CFR 892.2050, System, Image Processing, Radiological Regulatory Class: II Product Code: LLZ III. PREDICATE DEVICE K123174 - GE Healthcare Centricity PACS-IW with Universal Viewer This predicate device was subject to ONE design-related recall in Oct-13… | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182419 | Centricity Universal Viewer | 2018 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2026 | Class II | Z-1570-2026 | Software design | 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 unauthorized individual to potentially… |
| Feb 19, 2025 | Class II | Z-1483-2025 | Software design | 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 service login credentials are able to be… |
| Sep 14, 2023 | Class II | Z-0140-2024 | Software design | 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 Viewer V5.0 and Centricity Universal… |
| Mar 28, 2023 | Class II | Z-1501-2023 | Other | 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-0722-2023 | Software Manufacturing/Software Deployment | 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 result in a delay in reading the study. |
| Jul 15, 2022 | Class II | Z-1566-2022 | Process design | Inaccurate Distance and Area measurements with use of Global Stack viewport. |
| Aug 6, 2021 | Class II | Z-2503-2021 | Software design | Image acquisition failures and synchronization failure with the Centricity Enterprise Archive |
| Dec 16, 2019 | Class II | Z-0819-2020 | Software design | Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis. |
| May 17, 2019 | Class II | Z-1886-2019 | Software design | There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer. |
| May 16, 2019 | Class II | Z-1910-2019 | 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. |
| Dec 20, 2018 | Class II | Z-0793-2019 | Software design | When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect… |
| Oct 11, 2018 | Class II | Z-0375-2019 | Software design | Synchronization failure |
| Aug 30, 2018 | Class II | Z-0195-2019 | Component design/selection | Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present. |
| Jan 25, 2018 | Class II | Z-2102-2018 | Software design | 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-0226-2016 | Software design | Inaccurate distance measurements with magnified projection X-ray images. |
The 5 latest of 15 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 21 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K182419 (GE Healthcare, 2018) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K123174.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.…
Read the full statement (122 words)
Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed.
Typical users of this system are authorized healthcare professionals.
Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Mammography 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150420 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150420: Centricity Universal Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150420
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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