510(k) · Cleared
Recalled · Class II · 2023Universal 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 21, 2021 as substantially equivalent to K182419 (GE Healthcare, 2018) after a 21-day review. Its family tree reaches back 9 generations to 1994. 1 later device descends from it. It has been recalled 2 times.
- Decided
- May 21, 2021
- Review
- 21 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 9 generations to K942120 (1994). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 5 generations between
- 3 generations backK123174 Centricity Pacs-IW with Universal ViewerGE Healthcare · 2012 · Recalled
- 2 generations backK150420 Centricity Universal ViewerGE Healthcare · 2015 · Recalled
- 1 generation backK182419 Centricity Universal ViewerGE Healthcare · 2018 · Recalled
- This deviceK211312 Universal ViewerGE Healthcare · 2021
- Descendant · cites it directly · 0 of its ownK253639 ViewGE Healthcare · 2026
Show all 9 generations
- Root · 9 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 8 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 7 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 6 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 5 generations backK082318 Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions · 2008 · Recalled
- 4 generations backK121387 Centricity Pacs-IWGe Healthcare Integrated IT Solutions · 2012 · Recalled
- 3 generations backK123174 Centricity Pacs-IW with Universal ViewerGE Healthcare · 2012 · Recalled
- 2 generations backK150420 Centricity Universal ViewerGE Healthcare · 2015 · Recalled
- 1 generation backK182419 Centricity Universal ViewerGE Healthcare · 2018 · Recalled
- This deviceK211312 Universal ViewerGE Healthcare · 2021
Most influential descendants
Showing 1 of 1 · See all- K253639ViewGE Healthcare · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −8 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −7 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −6 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −5 | K082318 | Centricity Pacs IW | Ge Healthcare Dynamic Imaging Solutions | 2008 | 7 |
| −4 | K121387 | Centricity Pacs-IW | Ge Healthcare Integrated IT Solutions | 2012 | 1 |
| −3 | K123174 | Centricity Pacs-IW with Universal Viewer | GE Healthcare | 2012 | 10 |
| −2 | K150420 | Centricity Universal Viewer | GE Healthcare | 2015 | 15 |
| −1 | K182419 | Centricity Universal Viewer | GE Healthcare | 2018 | 8 |
| 0 (this device) | K211312 | Universal Viewer | GE Healthcare | 2021 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K182419 | Centricity Universal ViewerSummary page 4…LLZ Regulatory Class: Class II Predicate Device: Centricity Universal Viewer 510(k) number K182419 Regulation Number: 21CFR 892.2050 – Picture Archiving and Communications System Product Code: LLZ Regulator… | 2018 |
| † | K110875 | Centricity Pacs | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253639 | View | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 8, 2023 | Class II | Z-0143-2024 | Software design | When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer. |
| Jul 15, 2022 | Class II | Z-1566-2022 | Process design | Inaccurate Distance and Area measurements with use of Global Stack viewport. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 7 of the 16 ancestors have a recall of any class.
- Of its descendants, K253639 (GE Healthcare, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Universal Viewer is a software application that displays medical image data and associated clinical reports to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display and measurement of image data.
Typical users of this system are authorized healthcare professionals.
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.
Lossy compressed mammographic images and digitized film screen images should not be reviewed for primary image interpretations with use of the Universal Viewer.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211312 · printed Nov 5, 2026
Cite this page
510(k) Report. “K211312: Universal Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K211312
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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