510(k) · Cleared
Recalled · Class II · 2013Centricity Pacs Web Diagnostic
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 Nov 14, 2008 as substantially equivalent to K072986 (GE Healthcare, 2007) and 1 other predicate after a 36-day review. Its family tree reaches back 5 generations to 1991. 9 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 14, 2008
- Review
- 36 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 5 generations to K913770 (1991). 10 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 2 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 1 generation backK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- This deviceK083018 Centricity Pacs Web DiagnosticGe Healthcare Dynamic Imaging Solutions · 2008
- Descendant · cites it directly · 7 of its ownK112974 Picture Archiving and Communications SystemCurve Dental, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK132342 XVWEBApteryx, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK210682 SOTA Cloud ImagingSota Precision Optics, Inc. Dba Sota Imaging · 2021
- Descendant · 3 generations on · 0 of its ownK253111 Aeka ImagingGood Methods Global, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251880 Archy Dental ImagingArchy Dental, Inc. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K112974Picture Archiving and Communications SystemCurve Dental, Inc. · 2011 · cites it directly7descendants
- K132342XVWEBApteryx, Inc. · 2013 · cites it directly3descendants
- K210682SOTA Cloud ImagingSota Precision Optics, Inc. Dba Sota Imaging · 2021 · 2 generations on1descendant
- K253111Aeka ImagingGood Methods Global, Inc. · 2026 · 3 generations on0descendants
- K251880Archy Dental ImagingArchy Dental, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −3 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −2 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −1 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| 0 (this device) | K083018 | Centricity Pacs Web Diagnostic | Ge Healthcare Dynamic Imaging Solutions | 2008 | — |
| +1 | K112974 | Picture Archiving and Communications System | Curve Dental, Inc. | 2011 | — |
| +1 | K132342 | XVWEB | Apteryx, Inc. | 2013 | — |
| +2 | K210682 | SOTA Cloud Imaging | Sota Precision Optics, Inc. Dba Sota Imaging | 2021 | — |
| +3 | K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026 | — |
| +2 | K251880 | Archy Dental Imaging | Archy Dental, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K072986 | Integradweb Pacs SystemSummary page 1…assification Name: Picture Archiving Communications System Proprietary Name: Centricity PACS Web Diagnostic (Web DX) PACS System Predicate Devices: #K072986 IntegradWeb TM PACS System by GE Healthcare Dynamic Imaging Solutions #K043415 Centricity PACS System b… | 2007 |
| * | K043415 | Centricity Pacs SystemSummary page 1…S Web Diagnostic (Web DX) PACS System Predicate Devices: #K072986 IntegradWeb TM PACS System by GE Healthcare Dynamic Imaging Solutions #K043415 Centricity PACS System by GE Medical Systems Device Description: Centricity PACS Web Diagnostic (Web DX) PACS System isan Interne… | 2005 |
What descends from it? (9)
3 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 |
|---|---|---|---|---|
| Feb 18, 2013 | Class II | Z-1782-2017 | Software design | It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder. |
| Jun 15, 2012 | Class II | Z-0118-2014 | Software design | Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intention. 2.a) In the case… |
| Feb 18, 2010 | Not classified | Z-1395-2010 | 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-1403-2010 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K112974 (Curve Dental, Inc., 2011) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K072986.
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 Web Diagnostic (Web DX) PACS System by 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…
Read the full statement (114 words)
Centricity PACS Web Diagnostic (Web DX) PACS System by 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/K083018 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083018: Centricity Pacs Web Diagnostic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083018
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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