510(k) · Cleared
Recalled · Class II · 2015Centricity Pacs-IW
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Integrated IT Solutions · LLZ System, Image Processing, Radiological
Cleared on Jun 5, 2012 as substantially equivalent to K082318 (Ge Healthcare Dynamic Imaging Solutions, 2008) after a 28-day review. Its family tree reaches back 5 generations to 1994. 16 later devices descend from it. It has been recalled once.
- Decided
- Jun 5, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K942120 (1994). 12 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 4 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 3 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 2 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 1 generation backK082318 Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions · 2008 · Recalled
- This deviceK121387 Centricity Pacs-IWGe Healthcare Integrated IT Solutions · 2012
- Descendant · cites it directly · 15 of its ownK123174 Centricity Pacs-IW with Universal ViewerGE Healthcare · 2012 · Recalled
- Descendant · 2 generations on · 6 of its ownK131977 Centricity Universal Viewer Zero Footprint ClientGE Healthcare · 2013 · Recalled
- Descendant · 3 generations on · 5 of its ownK141881 RapidresultsRamsoft, Inc. · 2014
- Descendant · 4 generations on · 3 of its ownK222476 OmegaAI Image ViewerRamsoft, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK150420 Centricity Universal ViewerGE Healthcare · 2015 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K123174Centricity Pacs-IW with Universal ViewerGE Healthcare · 2012 · cites it directly15descendants
- K131977Centricity Universal Viewer Zero Footprint ClientGE Healthcare · 2013 · 2 generations on6descendants
- K141881RapidresultsRamsoft, Inc. · 2014 · 3 generations on5descendants
- K222476OmegaAI Image ViewerRamsoft, Inc. · 2022 · 4 generations on3descendants
- K150420Centricity Universal ViewerGE Healthcare · 2015 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −4 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −3 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −2 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −1 | K082318 | Centricity Pacs IW | Ge Healthcare Dynamic Imaging Solutions | 2008 | 7 |
| 0 (this device) | K121387 | Centricity Pacs-IW | Ge Healthcare Integrated IT Solutions | 2012 | — |
| +1 | K123174 | Centricity Pacs-IW with Universal Viewer | GE Healthcare | 2012 | 10 |
| +2 | K131977 | Centricity Universal Viewer Zero Footprint Client | GE Healthcare | 2013 | 8 |
| +3 | K141881 | Rapidresults | Ramsoft, Inc. | 2014 | — |
| +4 | K222476 | OmegaAI Image Viewer | Ramsoft, Inc. | 2022 | — |
| +2 | K150420 | Centricity Universal Viewer | GE Healthcare | 2015 | 15 |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K082318 | Centricity Pacs IWSummary page 1…ation Names: 21 CFR 892.2050, System, Image Processing, Radiological Product Code: LLZ Predicate Device: K082318 - GE Healthcare Centricity PACS-IW GE, the GE Monogram and Centricity are trademaorks of General Electric Company… | 2008 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123174 | Centricity Pacs-IW with Universal Viewer | 2012 | 15 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2015 | Class II | Z-0023-2016 | Software Design Change | Images may be missing when a system parameter MapRoute is set to a value greater than 1. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K123174 (GE Healthcare, 2012) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K082318.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an…
Read the full statement (104 words)
Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor that offers at least five Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121387 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121387: Centricity Pacs-IW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121387
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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