510(k) Report

510(k) · Cleared

Cleared

Xeleris V Processing and Review Systems

K201103510(k) TraditionalCleared Sep 25, 2020154-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

  1. Root · 10 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
  2. 6 generations between
  3. 3 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
  4. 2 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
  5. 1 generation backK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
  6. This deviceK201103 Xeleris V Processing and Review SystemsGE Healthcare · 2020
  7. Descendant · cites it directly · 1 of its ownK221680 Xeleris V Processing and Review SystemGE Healthcare · 2023
  8. Descendant · 2 generations on · 0 of its ownK241350 Clarify DLGe Medical Systems Israel, Functional Imaging · 2025
  9. Descendant · cites it directly · 0 of its ownK233908 cNeuro cDATCombinostics OY · 2024
  10. Descendant · cites it directly · 0 of its ownK221984 InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd. · 2023
Show all 10 generations
  1. Root · 10 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
  2. 9 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
  3. 8 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
  4. 7 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
  5. 6 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
  6. 5 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
  7. 4 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
  8. 3 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
  9. 2 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
  10. 1 generation backK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
  11. 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

GenerationNumberDeviceApplicantDecidedRecalls
−10K010641GE CT-Pet SystemGe Medical Systems, Inc.2001—
−9K023988GE Discovery LS SystemGE Medical Systems20031
−8K040172Modification to GE Discovery LS SystemGE Medical Systems20045
−7K041543GE Discovery STGE Healthcare20041
−6K042863SceniumSiemens Molecular Imaging, Ltd.2004—
−5K061545Scenium 1.1Siemens Molecular Imaging, Ltd.2006—
−4K121074Scenium 2.0Siemens Medical Solutions USA, Inc.2012—
−3K123528SceniumSiemens Medical Solutions USA, Inc.2012—
−2K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa2013—
−1K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare2016—
0 (this device)K201103Xeleris V Processing and Review SystemsGE Healthcare2020—
+1K221680Xeleris V Processing and Review SystemGE Healthcare2023—
+2K241350Clarify DLGe Medical Systems Israel, Functional Imaging2025—
+1K233908cNeuro cDATCombinostics OY2024—
+1K221984InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199710
200020
200110
200220
200310
200410
200520
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202320
202410
202510
FIG. 1 — Lineage of K201103, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230955 syngo Application Softwarescore 21.6 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K153355Xeleris 4.0 Processing and Review Workstation
Summary 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…
GE Healthcare2016—
†K191262aBSIExini Diagnostics AB2019—
†K133649Hepatic VcarGE Medical Systems SCS2014—

Also cleared against K153355: 2 other devices →

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K221680Xeleris V Processing and Review SystemGE Healthcare20231
K233908cNeuro cDATCombinostics OY20240
K221984InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd.20230

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 devices

LLZ 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

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

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.

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