510(k) · Cleared
Recalled · Class II · 2023Centricity Pacs IW
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Dynamic Imaging Solutions · LLZ System, Image Processing, Radiological
Cleared on Aug 25, 2008 as substantially equivalent to K031311 (Dynamic Imaging, Inc., 2003) and 3 other predicates after a 12-day review. Its family tree reaches back 4 generations to 1994. 18 later devices descend from it. It has been recalled 7 times.
- Decided
- Aug 25, 2008
- Review
- 12 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 7
- Predicates
- 4
Its longest line of descent runs back 4 generations to K942120 (1994). 11 ancestors in all. 18 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 3 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 2 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 1 generation backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- This deviceK082318 Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions · 2008
- Descendant · cites it directly · 16 of its ownK121387 Centricity Pacs-IWGe Healthcare Integrated IT Solutions · 2012 · Recalled
- Descendant · 2 generations on · 15 of its ownK123174 Centricity Pacs-IW with Universal ViewerGE Healthcare · 2012 · Recalled
- Descendant · 3 generations on · 6 of its ownK131977 Centricity Universal Viewer Zero Footprint ClientGE Healthcare · 2013 · Recalled
- Descendant · 4 generations on · 5 of its ownK141881 RapidresultsRamsoft, Inc. · 2014
- Descendant · 5 generations on · 3 of its ownK222476 OmegaAI Image ViewerRamsoft, Inc. · 2022
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K121387Centricity Pacs-IWGe Healthcare Integrated IT Solutions · 2012 · cites it directly16descendants
- K123174Centricity Pacs-IW with Universal ViewerGE Healthcare · 2012 · 2 generations on15descendants
- K131977Centricity Universal Viewer Zero Footprint ClientGE Healthcare · 2013 · 3 generations on6descendants
- K141881RapidresultsRamsoft, Inc. · 2014 · 4 generations on5descendants
- K222476OmegaAI Image ViewerRamsoft, Inc. · 2022 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −3 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −2 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −1 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| 0 (this device) | K082318 | Centricity Pacs IW | Ge Healthcare Dynamic Imaging Solutions | 2008 | — |
| +1 | K121387 | Centricity Pacs-IW | Ge Healthcare Integrated IT Solutions | 2012 | 1 |
| +2 | K123174 | Centricity Pacs-IW with Universal Viewer | GE Healthcare | 2012 | 10 |
| +3 | K131977 | Centricity Universal Viewer Zero Footprint Client | GE Healthcare | 2013 | 8 |
| +4 | K141881 | Rapidresults | Ramsoft, Inc. | 2014 | — |
| +5 | K222476 | OmegaAI Image Viewer | Ramsoft, Inc. | 2022 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K031311 | Integradweb by Dynamic Imaging, Inc.Summary page 1…August 12, 2008 Classification Name: Picture Archiving Communications System Proprietary Name: Centricity PACS IWTMPACS System Predicate Devices: #K031311 IntegradWebTM PACS System by Dynamic Imaging, Inc. #K042313 IntegradWeb TM MRP/MIP TM by Dynamic Imagi… | 2003 |
| * | K042313 | Integradweb MPR/MipSummary page 1…rietary Name: Centricity PACS IWTMPACS System Predicate Devices: #K031311 IntegradWebTM PACS System by Dynamic Imaging, Inc. #K042313 IntegradWeb TM MRP/MIP TM by Dynamic Imaging, Inc. #K072986 IntegradWeb TMPACS System by GE Healthcare… | 2004 |
| * | K072986 | Integradweb Pacs SystemSummary page 1…311 IntegradWebTM PACS System by Dynamic Imaging, Inc. #K042313 IntegradWeb TM MRP/MIP TM by Dynamic Imaging, Inc. #K072986 IntegradWeb TMPACS System by GE Healthcare Dynamic Imaging Solutions #K051673 Xeleris 2 Processing and… | 2007 |
| * | K051673 | Xeleris 2 Processing and Review WorkstationSummary page 1…MRP/MIP TM by Dynamic Imaging, Inc. #K072986 IntegradWeb TMPACS System by GE Healthcare Dynamic Imaging Solutions #K051673 Xeleris 2 Processing and Review Workstation by GE Medical Systems Device Description: Centricity PACS IWTMPACS System isan Intern… | 2005 |
What descends from it? (18)
See all 182 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2023 | Class II | Z-0138-2024 | 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-1502-2023 | Other | GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information. |
| May 22, 2019 | Class II | Z-1781-2019 | Software design | There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer. |
| Feb 23, 2018 | Class II | Z-1302-2018 | Software design | A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or more image series (i.e. all images within an image set) may… |
| 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. |
| Feb 18, 2010 | Not classified | Z-1394-2010 | Software design | There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software related to use of built-in reconstruction functions which may result in incorrect anatomic orientation markers. |
| Feb 11, 2010 | Not classified | Z-1402-2010 | Software design (manufacturing process) | There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software when dragging-and-dropping images from the Navigator causing flipping of the images that may impact patient safety. |
The 5 latest of 7 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 14 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K121387 (Ge Healthcare Integrated IT Solutions, 2012) has gone furthest, with 16 descendants of its own.
- 1 other device also cites its predicate K031311.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 lW TMby GE Healthcare Dynamic Imaging Solutions 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…
Read the full statement (109 words)
Centricity PACS lW TMby GE Healthcare Dynamic Imaging Solutions 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 5 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/K082318 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082318: 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/K082318
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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