510(k) · Cleared
ClearedXeleris 4.0 Processing and Review Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · LLZ System, Image Processing, Radiological
Cleared on Mar 16, 2016 as substantially equivalent to K130884 (Ge Medical Systems F.I. Haifa, 2013) after a 117-day review. Its family tree reaches back 9 generations to 2001. 60 later devices descend from it.
- Decided
- Mar 16, 2016
- Review
- 117 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K010641 (2001). 22 ancestors in all, the oldest K914350 (1991). 60 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 5 generations between
- 3 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 2 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 1 generation backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- This deviceK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- Descendant · cites it directly · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- Descendant · 2 generations on · 30 of its ownK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- Descendant · 2 generations on · 14 of its ownK190379 MIM on LinuxMim Software, Inc. · 2019
- Descendant · 3 generations on · 6 of its ownK193562 AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. · 2020
- Descendant · 3 generations on · 6 of its ownK193252 Contour ProtegeAIMim Software, Inc. · 2020
Show all 9 generations
- Root · 9 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 8 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 7 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 6 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 5 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 4 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- 3 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 2 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 1 generation backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- This deviceK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · cites it directly53descendants
- K191928AccuContourXiamen Manteia Technology, Ltd. · 2020 · 2 generations on30descendants
- K190379MIM on LinuxMim Software, Inc. · 2019 · 2 generations on14descendants
- K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. · 2020 · 3 generations on6descendants
- K193252Contour ProtegeAIMim Software, Inc. · 2020 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −8 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −7 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −6 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −5 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −4 | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| −3 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −2 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −1 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| 0 (this device) | K153355 | Xeleris 4.0 Processing and Review Workstation | GE Healthcare | 2016 | — |
| +1 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| +2 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
| +2 | K190379 | MIM on Linux | Mim Software, Inc. | 2019 | — |
| +3 | K193562 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +3 | K193252 | Contour ProtegeAI | Mim Software, Inc. | 2020 | — |
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 |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 7 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 9 | 0 |
| 2025 | 10 | 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? (1)
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 |
|---|---|---|---|
| * | K130884 | Xeleris 3.1 Processing and Review WorkstationSummary page 5…are built upon the existing technologies of the predicate device Xeleris 3.1 Processing and Review Workstation (K130884). It is of comparable type and substantially equivalent to its predicate… | 2013 |
| † | K103480 | Thoracic Vcar | 2011 |
| † | K141074 | Cortex ID Suite | 2014 |
| † | K101279 | CORRIDOR4DM V2010 Model: V2010 | 2010 |
What descends from it? (60)
See all 603 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)
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 15 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 22 ancestors have a recall of any class.
- Of its descendants, K182624 (Mim Software, Inc., 2018) has gone furthest, with 53 descendants of its own.
- 5 other devices also cite its predicate K130884.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 NMI 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 run on dedicated workstation or in a server-client…
Read the full statement (386 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 NMI 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 run 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 123I-ioflupane (DaTscanTM) images. DaTQUANT Normal Database option enables quantification relative to normal population databases of 123I-ioflupane (DaTscanTM) images. These applications may assist in detection of loss of functional dopamninergic neuron terminals in the striatum, which is correlated with Parkinson disease.
Q.Lung application may aid physicians in:
• Diagnosis of Pulmonary Embolism (PE), Chronic Obstructive Pulmonary Disease (COPD), Emphysema and other lung deficiencies.
• Assess the fraction of total lung function provided by a lobe or whole lung for Lung cancer resection requiring removal of an entire lobe, bilobectomy or pneumonectomy.
Q.Brain allows the user to visualize and quantify relative changes in the brain’s metabolic function or blood flow activity between a subject’s images and controls, when used with radiopharmaceuticals approved by the regulatory authority in the country of use, which may be resulting from brain function alterations in:
• Epileptic seizures
• Dementia, such as Alzheimer’s disease, Lewy body dementia, Parkinson’s disease with dementia, vascular dementia, and frontotemporal dementia.
• Inflammation
• Brain death
• Cerebrovascular disease such as acute stroke, chronic and acute ischemia
• Traumatic Brain Injury (TBI)
When integrated with the patient’s clinical and diagnostic information, Q.Brain application may aid the physician in the interpretation of cognitive complaints, neuro-degenerative disease processes and brain injuries.
The Alcyone CFR application allows for the quantification of coronary vascular function by deriving Myocardial Blood Flow (MBF) and then calculating Coronary Flow Reserve (CFR) indices on data acquired on PET scanners and on stationary SPECT scanners with the capacity for dynamic SPECT imaging. These indices may add information to physicians using Myocardial Perfusion Imaging for the diagnosis of Coronary Artery Disease (CAD).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153355: Xeleris 4.0 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/K153355
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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