510(k) · Cleared
Recalled · Class II · 2026Centricity Pacs System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · LLZ System, Image Processing, Radiological
Cleared on Jan 21, 2005 as substantially equivalent to K023557 (GE Medical Systems, 2002) and 1 other predicate after a 39-day review. Its family tree reaches back 4 generations to 1991. 1 of the 333 devices in its family, counting itself, has a Class I recall. 324 later devices descend from it. It has been recalled 23 times.
- Decided
- Jan 21, 2005
- Review
- 39 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 23
- Predicates
- 2
Its longest line of descent runs back 4 generations to K913770 (1991). 8 ancestors in all. 324 later devices descend from it, 11 citing it directly. 1 of the 333 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 3 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 2 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 1 generation backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- This deviceK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005
- Descendant · cites it directly · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 2 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 79 of its ownK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
- Descendant · 3 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- Descendant · 2 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
Showing 5 of 324 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 324 · See all- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · cites it directly287descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on200descendants
- K103576Mim 5.2 (Brachy)Mim Software, Inc. · 2011 · 2 generations on79descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 3 generations on76descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · 2 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −3 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −2 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −1 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| 0 (this device) | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | — |
| +1 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K103576 | Mim 5.2 (Brachy) | Mim Software, Inc. | 2011 | — |
| +3 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| +2 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 13 | 0 |
| 2017 | 13 | 0 |
| 2018 | 25 | 0 |
| 2019 | 21 | 0 |
| 2020 | 25 | 0 |
| 2021 | 22 | 0 |
| 2022 | 28 | 0 |
| 2023 | 25 | 0 |
| 2024 | 27 | 0 |
| 2025 | 36 | 1 |
| 2026 | 36 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K023557 | Centricity Pacs PlusSummary page 1…ure Archiving and Communications Systems and Workstation Classification Names: 21 CFR 892.2050 System, Image Processing, Radiological Predicate Device: K023557: Centricity™ PACS Plus K033400: Seno Advantage Device Description: The Centricity™ PACS… | 2002 |
| * | K033400 | Seno AdvantageSummary page 1…Classification Names: 21 CFR 892.2050 System, Image Processing, Radiological Predicate Device: K023557: Centricity™ PACS Plus K033400: Seno Advantage Device Description: The Centricity™ PACS include the following major components:… | 2003 |
What descends from it? (324)
See all 32411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071964 | Mim 4.1 (Seastar) | 2007 | 287 |
| K083018 | Centricity Pacs Web Diagnostic | 2008 | 9 |
| K063267 | Isite Pacs, V 4. X | 2006 | 8 |
| K110875 | Centricity Pacs | 2011 | 6 |
| K053458 | WEB1000 | 2005 | 5 |
| K112096 | Imagelink | 2011 | 0 |
| K081948 | Raypax System | 2008 | 0 |
| K071492 | Firstview | 2007 | 0 |
| K062757 | Xeron Pacs | 2006 | 0 |
| K061372 | Centricity AW Suite Option | 2006 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2026 | Class II | Z-3171-2026 | Under Investigation by firm | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead… |
| Jul 31, 2026 | Class II | Z-3166-2026 | Under Investigation by firm | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead… |
| Jul 31, 2026 | Class II | Z-3169-2026 | Under Investigation by firm | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead… |
| Jul 31, 2026 | Class II | Z-3167-2026 | Under Investigation by firm | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead… |
| Jul 31, 2026 | Class II | Z-3170-2026 | Under Investigation by firm | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead… |
| Jul 31, 2026 | Class II | Z-3168-2026 | Under Investigation by firm | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead… |
| Aug 5, 2024 | Class II | Z-3214-2024 | Device Design | GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study. |
| Apr 3, 2014 | Class II | Z-1665-2014 | Software design | It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed study, images for the previously displayed… |
| Jun 11, 2013 | Class II | Z-0116-2014 | Software design | GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and a RIS-Driven… |
| Feb 18, 2013 | Class II | Z-1214-2015 | Software design | Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on… |
| Nov 15, 2012 | Class II | Z-2579-2016 | Software design | While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are opened at the same… |
| Sep 15, 2012 | Class II | Z-0731-2014 | Software design | There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring from the source to a destination server.… |
| Sep 25, 2009 | Not classified | Z-0456-2010 | Software design | There are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of GE Centricity PACS RA1000 Workstation software that may impact patient safety. |
| Apr 3, 2009 | Not classified | Z-1549-2009 | Software design | There is a potential safety issue associated with the use of GE Centricity PACS software related to configuration of DICOM query retrieval with rejected images. |
| Mar 24, 2009 | Not classified | Z-1543-2009 | Software design | Software anomalies may allow the image orientation to be misinterpreted, posing a potential patient safety issue. |
| Jan 12, 2009 | Not classified | Z-0969-2009 | Software design | If a user site created a custom default display protocol (DDP) to display the current exam versus the historical exam and the user-defined DDP fails, the system displays the exams using a GE default hanging protocol. This may create a… |
| Dec 12, 2008 | Not classified | Z-0836-2009 | Software design | There is a potential patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it. |
| Nov 21, 2008 | Not classified | Z-0928-2009 | Software design | There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed. |
| Nov 20, 2008 | Not classified | Z-0970-2009 | Software design | Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam. |
| Sep 25, 2008 | Not classified | Z-0460-2009 | Software design | Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are… |
| May 6, 2008 | Not classified | Z-1826-2008 | Software design | A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis. |
| Dec 28, 2007 | Not classified | Z-1104-2008 | Software design | Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["], and apostrophe [']). This may not… |
| Jan 12, 2007 | Not classified | Z-0373-2007 | Other | The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential. |
The 5 latest of 23 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K071964 (Mimvista Corp., 2007) has gone furthest, with 287 descendants of its own.
- 5 other devices also cite its predicate K023557.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Centricity TM PACS provides scaleable image, data management and storage solutions for medical imaging. The system is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound…
Read the full statement (337 words)
The Centricity TM PACS provides scaleable image, data management and storage solutions for medical imaging. The system is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), and any other DICOM devices.
The Centricity TM PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity TM PACS infrastructure.
To be viewed for primary interpretation, the digital mammography images must be acquired from an FDA approved Full Field Digital Mammography (FFDM) device for primary interpretation. Furthermore, the FFDM must be able to provide, to the Centricity TM PACS, a viewable DICOM 'for presentation' mammography image as approved by the FDA for primary interpretation. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images.
To be viewed for primary diagnosis, digital mammography images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images.
The Web client software allows the user to display and manipulate images stored in the Centricity TM PACS or other DICOM archive device including the Centricity TM Enterprise Archive. The Centricity TM Web is not intended for primary diagnosis.
The Centricity TM Infrastructure provides for the system's database management, storage, printing, HL-7 interfacing, and all DICOM services such as Store, Print, Query/ Retrieve, Send, etc.
It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043415: Centricity Pacs System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043415
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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