510(k) · Cleared
ClearedXeleris 3.1 Processing and Review Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems F.I. Haifa · LLZ System, Image Processing, Radiological
Cleared on Apr 12, 2013 as substantially equivalent to K093982 (Ge Medical Systems F.I. Haifa, 2010) and 2 other predicates after a 14-day review. Its family tree reaches back 8 generations to 2001. 77 later devices descend from it.
- Decided
- Apr 12, 2013
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K010641 (2001). 21 ancestors in all, the oldest K914350 (1991). 77 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 7 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 6 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 5 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 4 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 3 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- 2 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 1 generation backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- This deviceK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- Descendant · cites it directly · 60 of its ownK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- Descendant · 2 generations on · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- Descendant · 3 generations on · 30 of its ownK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- Descendant · cites it directly · 15 of its ownK140269 Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB · 2014
- Descendant · 3 generations on · 14 of its ownK190379 MIM on LinuxMim Software, Inc. · 2019
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016 · cites it directly60descendants
- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · 2 generations on53descendants
- K191928AccuContourXiamen Manteia Technology, Ltd. · 2020 · 3 generations on30descendants
- K140269Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB · 2014 · cites it directly15descendants
- K190379MIM on LinuxMim Software, Inc. · 2019 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −7 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −6 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −5 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −4 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −3 | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| −2 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −1 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| 0 (this device) | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| +1 | K153355 | Xeleris 4.0 Processing and Review Workstation | GE Healthcare | 2016 | — |
| +2 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| +3 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
| +1 | K140269 | Hermes Medical Imaging Suite V5.4 | Hermes Medical Solutions AB | 2014 | — |
| +3 | K190379 | MIM on Linux | Mim Software, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 8 | 0 |
| 2023 | 10 | 0 |
| 2024 | 10 | 0 |
| 2025 | 11 | 0 |
| 2026 | 9 | 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? (3)
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 |
|---|---|---|---|
| * | K093982 | Xeleris 3 Processing and Review WorkstationSummary page 2…cessing, Radiological Product Code: Class 11 ;2 1CFR 892.2050 L LZ Predicate Device(s): K093982- Xeleris 3 Processing and Review workstation K02 1656- HERMES HDAQ Acquisition Station and… | 2010 |
| * | K021656 | Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4Summary page 2…L LZ Predicate Device(s): K093982- Xeleris 3 Processing and Review workstation K02 1656- HERMES HDAQ Acquisition Station and HERMES Workstation, Ver. 3.4… | 2002 |
| * | K123528 | SceniumSummary page 2…K02 1656- HERMES HDAQ Acquisition Station and HERMES Workstation, Ver. 3.4 K 123528- Scenium 3.0 Device Description: The Xeleris 3.1 is a Nuclear Medicine Workstation system… | 2012 |
What descends from it? (77)
See all 776 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153355 | Xeleris 4.0 Processing and Review Workstation | 2016 | 60 |
| K140269 | Hermes Medical Imaging Suite V5.4 | 2014 | 15 |
| K142631 | Hermes Medical Imaging Suite v5.5 | 2014 | 11 |
| K153056 | Hermes Medical Imaging Suite v5.6 | 2016 | 10 |
| K171681 | Hermes Medical Imaging Suite v5.7 | 2017 | 2 |
| K152822 | VidiStar HeartView | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 21 ancestors have a recall of any class.
- Of its descendants, K153355 (GE Healthcare, 2016) has gone furthest, with 60 descendants of its own.
- 4 other devices also cite its predicate K093982.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NM data, including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners. The system can mun on dedicated workstation or in a server-client configuration.…
Read the full statement (161 words)
The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NM data, including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners.
The system can mun on dedicated workstation or in a server-client configuration.
The NM or PET data can be coupled with registered and/or fused CT or MR scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes.
DaTQUANT optional application enables Visual evaluation and quantification of ' 231I loflup.ane (DaTscan TM ) images. DaTQUJANT Normal Database option enables quanrtification relative to normal population databases of 123I-ioflupane (DaTscan mT-) images.
These applications may assist in detection of loss of functional dopaminergic neuron terminals in the striatum., which is correlated with Parkinson disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130884: Xeleris 3.1 Processing and Review Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130884
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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