510(k) · Cleared
ClearedOnSight 3D Extremity System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 30, 2016 as substantially equivalent to K121418 (Planmed OY, 2013) after a 167-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Aug 30, 2016
- Review
- 167 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K973598 (1997). 15 ancestors in all, the oldest K941546 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 4 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 3 generations backK032243 Minicat DentocatXoran Technologies, Inc. · 2003 · Recalled
- 2 generations backK061834 Xcat; Xcat for NeuroXoran Technologies, Inc. · 2006
- 1 generation backK121418 Planmed VerityPlanmed OY · 2013
- This deviceK160723 OnSight 3D Extremity SystemCarestream Health, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK252249 Extremity CT Imaging SystemMars Bioimaging, Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252249Extremity CT Imaging SystemMars Bioimaging, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −4 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −3 | K032243 | Minicat Dentocat | Xoran Technologies, Inc. | 2003 | 3 |
| −2 | K061834 | Xcat; Xcat for Neuro | Xoran Technologies, Inc. | 2006 | — |
| −1 | K121418 | Planmed Verity | Planmed OY | 2013 | — |
| 0 (this device) | K160723 | OnSight 3D Extremity System | Carestream Health, Inc. | 2016 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K121418 | Planmed VeritySummary page 4…e DeviceTrade Name: Planmed Verity Manufactured by: Planmed Oy 510(k) No.: K121418 (February 1, 2013) Device Common Name: Computed Tomography X-ray System Classification Name:… | 2013 |
| † | K060937 | Brilliance Volume | 2006 |
| † | K120062 | DRX-Revolution Mobile X-Ray System | 2012 |
| † | K091889 | DRX-Evolution, Model VX3733-Sys | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252249 | Extremity CT Imaging System | 2026 | 0 |
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 19 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K252249 (Mars Bioimaging, Ltd., 2026) has gone furthest, with 0 descendants of its own.
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. 2016, 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?
The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 or over.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160723 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160723: OnSight 3D Extremity System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160723
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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