510(k) · Cleared
Recalled · Class II · 2026Centricity Universal Viewer Zero Footprint Client
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 Sep 17, 2013 as substantially equivalent to K123174 (GE Healthcare, 2012) after an 81-day review. Its family tree reaches back 7 generations to 1994. 6 later devices descend from it. It has been recalled 8 times.
- Decided
- Sep 17, 2013
- Review
- 81 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 7 generations to K942120 (1994). 14 ancestors in all. 6 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 deviceK131977 Centricity Universal Viewer Zero Footprint ClientGE Healthcare · 2013
- Descendant · cites it directly · 5 of its ownK141881 RapidresultsRamsoft, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK222476 OmegaAI Image ViewerRamsoft, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK254237 Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl. · 2026
- Descendant · 3 generations on · 0 of its ownK241546 aiCockpit AI ViewerFovia, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK242362 Lightning ViewerNexsys Electronics Inc. Dba Medweb · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141881RapidresultsRamsoft, Inc. · 2014 · cites it directly5descendants
- K222476OmegaAI Image ViewerRamsoft, Inc. · 2022 · 2 generations on3descendants
- K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl. · 2026 · 3 generations on0descendants
- K241546aiCockpit AI ViewerFovia, Inc. · 2025 · 3 generations on0descendants
- K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb · 2024 · 3 generations on0descendants
View 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) | K131977 | Centricity Universal Viewer Zero Footprint Client | GE Healthcare | 2013 | — |
| +1 | K141881 | Rapidresults | Ramsoft, Inc. | 2014 | — |
| +2 | K222476 | OmegaAI Image Viewer | Ramsoft, Inc. | 2022 | — |
| +3 | K254237 | Cci Pacs Viewer (Pacs-US-001) | CliniComp, Intl. | 2026 | — |
| +3 | K241546 | aiCockpit AI Viewer | Fovia, Inc. | 2025 | — |
| +3 | K242362 | Lightning Viewer | Nexsys Electronics Inc. Dba Medweb | 2024 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 1…Classification Names: 21 CFR 892.2050, System, Image Processing, Radiological Product Code: LLZ Predicate Device: K1 23174 - GE Healthcare Centricity PACS-IW with Universal Viewer Page 5 -… | 2012 |
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 |
|---|---|---|---|
| K141881 | Rapidresults | 2014 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2026 | Class II | Z-1475-2026 | Device Design | 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, SP11.6.0.1 and SP11.6.1 on systems with Patient… |
| Oct 3, 2024 | Class II | Z-0318-2025 | Software Manufacturing/Software Deployment | 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 the system and potentially manipulate… |
| Aug 29, 2024 | Class II | Z-0039-2025 | Process control | 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 occur when a study has multiple DICOM… |
| Jul 23, 2024 | Class II | Z-3160-2024 | Software Design Change | 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 original report but at a different time, and… |
| Jun 8, 2022 | Class II | Z-1333-2022 | Software design | Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP) |
| Apr 28, 2022 | Class II | Z-1229-2022 | 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… |
| Oct 15, 2021 | Class II | Z-0329-2022 | Software design | There is a potential to display incomplete patient imaging study. |
| Nov 9, 2018 | Class II | Z-0641-2019 | Software design | 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 on the image to which they were… |
The 5 latest of 8 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 19 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K141881 (Ramsoft, Inc., 2014) has gone furthest, with 5 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. 2013, 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 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…
Read the full statement (137 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131977 · printed Nov 4, 2026
Cite this page
510(k) Report. “K131977: Centricity Universal Viewer Zero Footprint Client.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K131977
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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