510(k) · Cleared
Recalled · 2011Xeleris 3 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 Jan 8, 2010 as substantially equivalent to K051673 (GE Medical Systems, 2005) after a 15-day review. Its family tree reaches back 3 generations to 2000. 134 later devices descend from it. It has been recalled once.
- Decided
- Jan 8, 2010
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000395 (2000). 134 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK000395 Einstein Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2000
- 2 generations backK024137 Jupiter Processing and Review WorkstationGe Medical Systems, Inc. · 2003 · Recalled
- 1 generation backK051673 Xeleris 2 Processing and Review WorkstationGE Medical Systems · 2005 · Recalled
- This deviceK093982 Xeleris 3 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2010
- Descendant · cites it directly · 77 of its ownK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- Descendant · cites it directly · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
- Descendant · 2 generations on · 60 of its ownK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- Descendant · 3 generations on · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- Descendant · cites it directly · 37 of its ownK102687 Mirada RTMirada Medical, Ltd. · 2010
Showing 5 of 134 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 134 · See all- K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013 · cites it directly77descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · cites it directly70descendants
- K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016 · 2 generations on60descendants
- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · 3 generations on53descendants
- K102687Mirada RTMirada Medical, Ltd. · 2010 · cites it directly37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000395 | Einstein Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2000 | — |
| −2 | K024137 | Jupiter Processing and Review Workstation | Ge Medical Systems, Inc. | 2003 | 2 |
| −1 | K051673 | Xeleris 2 Processing and Review Workstation | GE Medical Systems | 2005 | 3 |
| 0 (this device) | K093982 | Xeleris 3 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2010 | — |
| +1 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| +1 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| +2 | K153355 | Xeleris 4.0 Processing and Review Workstation | GE Healthcare | 2016 | — |
| +3 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| +1 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 7 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 9 | 0 |
| 2021 | 13 | 0 |
| 2022 | 14 | 0 |
| 2023 | 14 | 0 |
| 2024 | 15 | 0 |
| 2025 | 15 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | K051673 | Xeleris 2 Processing and Review WorkstationSummary page 1…em, Image Processing, Radiological Class II ;2I1CFR 892.2050 Product Code: LLZ Predicate Device(s): K051673 XELERIS 2 PROCESSING AND REVIEW WORKSTATION Device Description: XELERIS' 3 PROC… | 2005 |
What descends from it? (134)
See all 1345 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 12, 2011 | Not classified | Z-1250-2011 | Software design | GE 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K130884 (Ge Medical Systems F.I. Haifa, 2013) has gone furthest, with 77 descendants of its own.
- 6 other devices also cite its predicate K051673.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 run on dedicated workstation or in a server-client configuration.…
Read the full statement (107 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093982: Xeleris 3 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/K093982
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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