510(k) · Cleared
ClearedPlanmed Verity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Planmed OY · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 1, 2013 as substantially equivalent to K061834 (Xoran Technologies, Inc., 2006) after a 266-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Feb 1, 2013
- Review
- 266 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K973598 (1997). 14 ancestors in all, the oldest K941546 (1994). 2 later devices descend from it, 1 citing it directly.
- 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 backK061834 Xcat; Xcat for NeuroXoran Technologies, Inc. · 2006
- This deviceK121418 Planmed VerityPlanmed OY · 2013
- Descendant · cites it directly · 1 of its ownK160723 OnSight 3D Extremity SystemCarestream Health, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK252249 Extremity CT Imaging SystemMars Bioimaging, Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView 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 | K061834 | Xcat; Xcat for Neuro | Xoran Technologies, Inc. | 2006 | — |
| 0 (this device) | K121418 | Planmed Verity | Planmed OY | 2013 | — |
| +1 | K160723 | OnSight 3D Extremity System | Carestream Health, Inc. | 2016 | — |
| +2 | 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 |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K061834 | Xcat; Xcat for NeuroSummary page 2…We consider this product to be similar in design, composition and fuinction to the following device introduced into commercial distribution after May 28, 1976: 5 10(k) #K061834 Xoran xCATF'M SUBSTANTIAL EQUIVALENCE The intended use of Planmed Verity and the predicate device is similar. Planmed Verit… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160723 | OnSight 3D Extremity System | 2016 | 1 |
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 16 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K160723 (Carestream Health, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K061834.
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. 2013, this device’s year, is highlighted.
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?
Planmed Verity is intended to be used for X-ray computed tomography imaging of anatomnies within upper and lower extremities.
The device is to be operated and used by legally qualified health care professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121418: Planmed Verity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121418
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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