510(k) · Cleared
ClearedXeleris V Processing and Review Systems
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 Sep 25, 2020 as substantially equivalent to K153355 (GE Healthcare, 2016) after a 154-day review. Its family tree reaches back 10 generations to 2001. 4 later devices descend from it.
- Decided
- Sep 25, 2020
- Review
- 154 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010641 (2001). 23 ancestors in all, the oldest K914350 (1991). 4 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 6 generations between
- 3 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 2 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- 1 generation backK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- This deviceK201103 Xeleris V Processing and Review SystemsGE Healthcare · 2020
- Descendant · cites it directly · 1 of its ownK221680 Xeleris V Processing and Review SystemGE Healthcare · 2023
- Descendant · 2 generations on · 0 of its ownK241350 Clarify DLGe Medical Systems Israel, Functional Imaging · 2025
- Descendant · cites it directly · 0 of its ownK233908 cNeuro cDATCombinostics OY · 2024
- Descendant · cites it directly · 0 of its ownK221984 InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd. · 2023
Show all 10 generations
- Root · 10 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 9 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 8 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 7 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 6 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 5 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- 4 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 3 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 2 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- 1 generation backK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- This deviceK201103 Xeleris V Processing and Review SystemsGE Healthcare · 2020
Most influential descendants
Showing 4 of 4 · See all- K221680Xeleris V Processing and Review SystemGE Healthcare · 2023 · cites it directly1descendant
- K241350Clarify DLGe Medical Systems Israel, Functional Imaging · 2025 · 2 generations on0descendants
- K233908cNeuro cDATCombinostics OY · 2024 · cites it directly0descendants
- K221984InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −9 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −8 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −7 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −6 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −5 | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| −4 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −3 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −2 | 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 | — |
| 0 (this device) | K201103 | Xeleris V Processing and Review Systems | GE Healthcare | 2020 | — |
| +1 | K221680 | Xeleris V Processing and Review System | GE Healthcare | 2023 | — |
| +2 | K241350 | Clarify DL | Ge Medical Systems Israel, Functional Imaging | 2025 | — |
| +1 | K233908 | cNeuro cDAT | Combinostics OY | 2024 | — |
| +1 | K221984 | InterView XP; InterView FUSION | Mediso Medical Imaging Systems, Lttd. | 2023 | — |
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 |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 21.6 · 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 |
|---|---|---|---|
| * | K153355 | Xeleris 4.0 Processing and Review WorkstationSummary page 5…21CFR 892.2050 Names: Product LLZ Code: Predicate Device Name Xeleris 4.0 Processing and Review Workstation Device 510 (K) number K153355 Regulation Nº 892.2050 Product Code LLZ… | 2016 |
| † | K191262 | aBSI | 2019 |
| † | K133649 | Hepatic Vcar | 2014 |
What descends from it? (4)
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)
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 19 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 23 ancestors have a recall of any class.
- Of its descendants, K221680 (GE Healthcare, 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K153355.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 (479 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.
The 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 dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease.
The 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.
The Q.Brain application 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, 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).
The Exini Bone application is intended to be used with NM bone scans for the evaluation of adult male patients with bone metastases from prostate cancer. Exini Bone quantifies the selected lesions and provides a Bone Scan Index value as adjunct information related to the progression of disease.
The Q.Liver application provides processing, quantification, and multidimensional review of Liver SPECT/PET and CT images for display, segmentation, and a calculation of the SPECT ‘liver to lung’ shunt value and the patient’s Body Surface Area (BSA) for use in calculating a therapeutic dose for Selective Internal Radiation Therapy (SIRT) treatment using a user defined formula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201103 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201103: Xeleris V Processing and Review Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201103
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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