510(k) · Cleared
ClearedXcat; Xcat for Neuro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xoran Technologies, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 7, 2006 as substantially equivalent to K051765 (Neurologica Corporation, 2005) and 1 other predicate after a 39-day review. Its family tree reaches back 3 generations to 1997. 6 later devices descend from it.
- Decided
- Aug 7, 2006
- Review
- 39 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K973598 (1997). 13 ancestors in all, the oldest K941546 (1994). 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 2 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 1 generation backK032243 Minicat DentocatXoran Technologies, Inc. · 2003 · Recalled
- This deviceK061834 Xcat; Xcat for NeuroXoran Technologies, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK143435 Planmed VerityPlanmed OY · 2015
- Descendant · cites it directly · 2 of its ownK121418 Planmed VerityPlanmed OY · 2013
- Descendant · 2 generations on · 1 of its ownK180918 Planmed VerityPlanmed OY · 2018
- Descendant · 2 generations on · 1 of its ownK160723 OnSight 3D Extremity SystemCarestream Health, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK252249 Extremity CT Imaging SystemMars Bioimaging, Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K143435Planmed VerityPlanmed OY · 2015 · cites it directly2descendants
- K121418Planmed VerityPlanmed OY · 2013 · cites it directly2descendants
- K180918Planmed VerityPlanmed OY · 2018 · 2 generations on1descendant
- K160723OnSight 3D Extremity SystemCarestream Health, Inc. · 2016 · 2 generations on1descendant
- K252249Extremity CT Imaging SystemMars Bioimaging, Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −2 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −1 | K032243 | Minicat Dentocat | Xoran Technologies, Inc. | 2003 | 3 |
| 0 (this device) | K061834 | Xcat; Xcat for Neuro | Xoran Technologies, Inc. | 2006 | — |
| +1 | K143435 | Planmed Verity | Planmed OY | 2015 | — |
| +1 | K121418 | Planmed Verity | Planmed OY | 2013 | — |
| +2 | K180918 | Planmed Verity | Planmed OY | 2018 | — |
| +2 | K160723 | OnSight 3D Extremity System | Carestream Health, Inc. | 2016 | — |
| +3 | K252249 | Extremity CT Imaging System | Mars Bioimaging, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K051765 | Ceretom, Model NL3000Summary page 2…The xCAT TM is substantially equivalent in design, material, functionality, and technology to the predicate devices (Neurologica's NL 3000 CereTom, ref: K051765, and Xoran Technologies Inc. MiniCATTM ref: K032243). 1.20. Conclusion The xCATTM by Xoran Technologies acqui… | 2005 |
| * | K032243 | Minicat DentocatSummary page 2…material, functionality, and technology to the predicate devices (Neurologica's NL 3000 CereTom, ref: K051765, and Xoran Technologies Inc. MiniCATTM ref: K032243). 1.20. Conclusion The xCATTM by Xoran Technologies acquires an X-ray rotational sequence and provides three-… | 2003 |
What descends from it? (6)
2 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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K143435 (Planmed OY, 2015) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K051765.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The XCAT is intended to be used for x-ray computed tomography imaging of anatomy that safely fits into the imaging gantry (such as the head, neck, wrist, ankle, hand and foot).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061834 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061834: Xcat; Xcat for Neuro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061834
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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