510(k) · Cleared
ClearedXoran Workstation, Model 10050
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xoran Technologies, LLC · LLZ System, Image Processing, Radiological
Cleared on May 20, 2021 as substantially equivalent to K113421 (Xoran Technologies, Inc., 2012) after a 108-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- May 20, 2021
- Review
- 108 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K973598 (1997). 7 ancestors in all, the oldest K945375 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 3 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 2 generations backK032243 Minicat DentocatXoran Technologies, Inc. · 2003 · Recalled
- 1 generation backK113421 MinicatXoran Technologies, Inc. · 2012 · Recalled
- This deviceK210257 Xoran Workstation, Model 10050Xoran Technologies, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −3 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −2 | K032243 | Minicat Dentocat | Xoran Technologies, Inc. | 2003 | 3 |
| −1 | K113421 | Minicat | Xoran Technologies, Inc. | 2012 | 1 |
| 0 (this device) | K210257 | Xoran Workstation, Model 10050 | Xoran Technologies, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 21.5 · 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 |
|---|---|---|---|
| * | K113421 | MinicatSummary page 4…21 CFR 892.1750 Device Class: Class II Product Code: OAS Predicate Devices: Trade Name: MiniCAT 510(k) number: K113421 cleared 07/11/2012 Manufacturer: Xoran Technologies, LLC Classification Name: Computed Tomography X-Ray Sy… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- 4 of the 7 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Xoran Workstation is an image processing and viewing software. The Xoran Workstation software provides tools for patient data management, image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210257: Xoran Workstation, Model 10050.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210257
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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