510(k) · Cleared
ClearedCentricity Pacs Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · LLZ System, Image Processing, Radiological
Cleared on Nov 7, 2002 as substantially equivalent to K981217 (GE Medical Systems, 1998) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1992. 1 of the 357 devices in its family, counting itself, has a Class I recall. 354 later devices descend from it.
- Decided
- Nov 7, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920319 (1992). 2 ancestors in all. 354 later devices descend from it, 6 citing it directly. 1 of the 357 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK920319 Sienet Image Display Workstations, Image AcquisitiSiemens Gammasonics, Inc. · 1992
- This deviceK023557 Centricity Pacs PlusGE Medical Systems · 2002
- Descendant · cites it directly · 324 of its ownK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- Descendant · 2 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 3 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 79 of its ownK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
- Descendant · 4 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
Showing 5 of 354 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 354 · See all- K043415Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · cites it directly324descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 2 generations on287descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on200descendants
- K103576Mim 5.2 (Brachy)Mim Software, Inc. · 2011 · 3 generations on79descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 4 generations on76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920319 | Sienet Image Display Workstations, Image Acquisiti | Siemens Gammasonics, Inc. | 1992 | — |
| 0 (this device) | K023557 | Centricity Pacs Plus | GE Medical Systems | 2002 | — |
| +1 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| +2 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K103576 | Mim 5.2 (Brachy) | Mim Software, Inc. | 2011 | — |
| +4 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 12 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 9 | 0 |
| 2016 | 13 | 0 |
| 2017 | 14 | 0 |
| 2018 | 27 | 0 |
| 2019 | 23 | 0 |
| 2020 | 25 | 0 |
| 2021 | 23 | 0 |
| 2022 | 28 | 0 |
| 2023 | 26 | 0 |
| 2024 | 28 | 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 |
|---|---|---|---|
| * | K981217 | Platinum Reading, Review & Analysis WorkstationSummary page 1…d below: Model: Platinum Reading and Review Workstation Manufacturer: General Electric Medical Systems 510 (k): K98 12 17 Model: Siemens SieNET Manufacturer: General Electric Medical Systems 5 10 (k):… | 1998 |
| * | K920319 | Sienet Image Display Workstations, Image AcquisitiSummary page 1…510 (k): K98 12 17 Model: Siemens SieNET Manufacturer: General Electric Medical Systems 5 10 (k): K9203 19 4. Device Description : See Attachment #2 1/2… | 1992 |
What descends from it? (354)
See all 3546 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
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 PACS Plus system is used to transmit, store and display images throughout a clinical environment. The Centricity PACS Plus is an image display software application that is intended for reading, diagnostic review, and analysis of digital images acquired from imaging devices such as CT, MR, CR, DX, MG, US, NM, PET, and other devices. As a part of the PACS Plus system the Centricity RA1000 is used to view digital images that are obtained from a GE Centricity PACS System, or another DICOM device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023557: Centricity Pacs Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023557
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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