510(k) · Cleared
ClearedEinstein 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 May 3, 2000 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 207 later devices descend from it.
- Decided
- May 3, 2000
- Review
- 86 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
207 later devices descend from it, 3 citing it directly.
- This deviceK000395 Einstein Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2000
- Descendant · cites it directly · 193 of its ownK024137 Jupiter Processing and Review WorkstationGe Medical Systems, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 192 of its ownK051673 Xeleris 2 Processing and Review WorkstationGE Medical Systems · 2005 · Recalled
- Descendant · 3 generations on · 134 of its ownK093982 Xeleris 3 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2010 · Recalled
- Descendant · 4 generations on · 77 of its ownK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- Descendant · 4 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
Showing 5 of 207 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 207 · See all- K024137Jupiter Processing and Review WorkstationGe Medical Systems, Inc. · 2003 · cites it directly193descendants
- K051673Xeleris 2 Processing and Review WorkstationGE Medical Systems · 2005 · 2 generations on192descendants
- K093982Xeleris 3 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2010 · 3 generations on134descendants
- K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013 · 4 generations on77descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · 4 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000395 | Einstein Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2000 | — |
| +1 | K024137 | Jupiter Processing and Review Workstation | Ge Medical Systems, Inc. | 2003 | 2 |
| +2 | K051673 | Xeleris 2 Processing and Review Workstation | GE Medical Systems | 2005 | 3 |
| +3 | K093982 | Xeleris 3 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2010 | 1 |
| +4 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| +4 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 8 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 12 | 0 |
| 2017 | 13 | 0 |
| 2018 | 13 | 0 |
| 2019 | 8 | 0 |
| 2020 | 10 | 0 |
| 2021 | 16 | 0 |
| 2022 | 17 | 0 |
| 2023 | 17 | 0 |
| 2024 | 17 | 0 |
| 2025 | 20 | 0 |
| 2026 | 20 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (207)
See all 2073 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?
- Of its descendants, K024137 (Ge Medical Systems, Inc., 2003) has gone furthest, with 193 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K000395 · printed Nov 5, 2026
Cite this page
510(k) Report. “K000395: Einstein 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/K000395
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026