510(k) Report

510(k) · Cleared

Recalled · Class II · 2011

Xeleris 2 Processing and Review Workstation

K051673510(k) SpecialCleared Jul 18, 200525-day reviewClass II21 CFR 892.2050Recalls 3

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

GE Medical Systems · LLZ System, Image Processing, Radiological

Cleared on Jul 18, 2005 as substantially equivalent to K024137 (Ge Medical Systems, Inc., 2003) after a 25-day review. Its family tree reaches back 2 generations to 2000. 192 later devices descend from it. It has been recalled 3 times.

Decided
Jul 18, 2005
Review
25 days
Class
Class II
Product code
LLZ
Recalls
3
Predicates
1

Its longest line of descent runs back 2 generations to K000395 (2000). 192 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2013: 7 descendants cleared2010: 5 descendants cleared2009: 2 descendants cleared2008: 3 descendants cleared2006: 1 descendant cleared2020: 10 descendants cleared2023: 17 descendants cleared2016: 11 descendants cleared2012: 5 descendants cleared2011: 3 descendants cleared2015: 5 descendants cleared2014: 5 descendants cleared2017: 12 descendants cleared2018: 12 descendants cleared2022: 16 descendants cleared2021: 16 descendants cleared2024: 17 descendants cleared2019: 8 descendants cleared2025: 19 descendants cleared2026: 18 descendants clearedK000395 · Einstein Processing and Review Workstation · Ge Medical Systems F.I. Haifa · 2000K024137 · Jupiter Processing and Review Workstation · Ge Medical Systems, Inc. · 2003 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 7 descendants2 generations forward: 21 descendants3 generations forward: 26 descendants4 generations forward: 31 descendants5 generations forward: 31 descendants6 generations forward: 32 descendants7 generations forward: 22 descendants8 generations forward: 9 descendants9 generations forward: 6 descendants10 generations forward: 6 descendants11 generations forward: 1 descendant K024137 · Jupiter Processing and Review Workstation · Ge Medical Systems, Inc. · 2003 · recalledK000395 · Einstein Processing and Review Workstation · Ge Medical Systems F.I. Haifa · 20000+5+10
  1. Root · 2 generations backK000395 Einstein Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2000
  2. 1 generation backK024137 Jupiter Processing and Review WorkstationGe Medical Systems, Inc. · 2003 · Recalled
  3. This deviceK051673 Xeleris 2 Processing and Review WorkstationGE Medical Systems · 2005
  4. Descendant · cites it directly · 134 of its ownK093982 Xeleris 3 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2010 · Recalled
  5. Descendant · 2 generations on · 77 of its ownK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
  6. Descendant · 2 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
  7. Descendant · 3 generations on · 60 of its ownK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
  8. Descendant · 4 generations on · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018

Showing 5 of 192 descendants. See all descendants

Descendants cleared per year

2006: 12008: 32009: 22010: 52011: 32012: 52013: 72014: 52015: 52016: 112017: 122018: 122019: 82020: 102021: 162022: 162023: 172024: 172025: 192026: 18
2006high 19 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 192 · See all
  • K093982Xeleris 3 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2010 · cites it directly134descendants
  • K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013 · 2 generations on77descendants
  • K101228Mirada XDMirada Medical, Ltd. · 2010 · 2 generations on70descendants
  • K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016 · 3 generations on60descendants
  • K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · 4 generations on53descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K000395Einstein Processing and Review WorkstationGe Medical Systems F.I. Haifa2000—
−1K024137Jupiter Processing and Review WorkstationGe Medical Systems, Inc.20032
0 (this device)K051673Xeleris 2 Processing and Review WorkstationGE Medical Systems2005—
+1K093982Xeleris 3 Processing and Review WorkstationGe Medical Systems F.I. Haifa20101
+2K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa2013—
+2K101228Mirada XDMirada Medical, Ltd.2010—
+3K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare2016—
+4K182624MIM - MRT DosimetryMim Software, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200830
200920
201050
201130
201250
201370
201450
201550
2016110
2017120
2018120
201980
2020100
2021160
2022160
2023170
2024170
2025190
2026180
FIG. 1 — Lineage of K051673, 2000–2026Source: 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 21.5 · 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
*K024137Jupiter Processing and Review Workstation
Summary page 1
…logical, 21 CIFR 892.2050, 90-LLZ Marketed Device: GE MEDICAL SYSTEM'S XELERIS PROCESSING AND REVIEW WORKSTATION; 51 0(k) Number K024137, currently in commercial distribution (first introduced under the name Jupiter). Device Description…
Ge Medical Systems, Inc.20032

What descends from it? (192)

See all 192

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

NumberDeviceApplicantDecidedDescendants
K093982Xeleris 3 Processing and Review WorkstationGe Medical Systems F.I. Haifa2010134
K0810933-D Imaging WorkstationEigen, LLC200831
K082318Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions200818
K131233Hermes Medical Imaging Suite V5.3Hermes Medical Solutions AB201316
K091073WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering CorrectionsUltraspect, Ltd.20091
K061587Fullcard AnalysisGE Healthcare20061
K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa20080

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 6, 2011Class IIZ-1164-2013Software designGE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may impact patient safety. On imported CT scans, Myocardial Perfusion Imaging (MPI) studies may…
Jan 12, 2011Not classifiedZ-1250-2011Software designGE Healthcare has become aware of safety issues relevant for the Xeleris Workstation 1.0, 1.1, 2.0, 2.1, 3.0: 1. Measurements taken on the CT Images on the CT system are different from the Xeleris Workstation 2. Inaccurate PET SUV values…
Oct 27, 2010Not classifiedZ-0537-2011OtherGE Healthcare has become aware of inaccurate user protocol setup associated with the Thyroid Uptake Index application on certain Xeleris workstations(1.0, 1.1, 2.0, 2.1) that may impact patient safety. Inaccurate protocol setup by the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K093982 (Ge Medical Systems F.I. Haifa, 2010) has gone furthest, with 134 descendants of its own.

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.

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 display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration.

Indications for use as stated in the FDA summary.

More from GE Medical Systems

170 FDA decisions under this applicant name. See the company

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  • K220848Venue FitGE Medical Systems · 20221 recall
  • K220851VenueGE Medical Systems · 2022
  • K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 20173 recalls
  • K103411Ideal IQ Software OptionGE Medical Systems · 2011

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K051673 · printed Nov 5, 2026

Cite this page

510(k) Report. “K051673: Xeleris 2 Processing and Review Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051673

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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