510(k) · Cleared
ClearedOmniTom Elite with PCD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurologica Corporation · JAK System, X-Ray, Tomography, Computed
Cleared on Sep 8, 2025 as substantially equivalent to K233767 (Neurologica Corporation, 2024) after a 164-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Sep 8, 2025
- Review
- 164 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K944131 (1995). 12 ancestors in all, the oldest K941546 (1994). No later device cites it as a predicate yet.
- Root · 8 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 7 generations backK964890 Anatom 2000Analogic Corp. · 1997
- 6 generations backK051765 Ceretom, Model NL3000Neurologica Corporation · 2005
- 5 generations backK171183 OmniTomNeurologica Corporation · 2017 · Recalled
- 4 generations backK202526 OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2020 · Recalled
- 3 generations backK211711 OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2022
- 2 generations backK223447 OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung · 2023
- 1 generation backK233767 OmniTom EliteNeurologica Corporation · 2024
- This deviceK250928 OmniTom Elite with PCDNeurologica Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| −7 | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| −6 | K051765 | Ceretom, Model NL3000 | Neurologica Corporation | 2005 | — |
| −5 | K171183 | OmniTom | Neurologica Corporation | 2017 | 2 |
| −4 | K202526 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2020 | 1 |
| −3 | K211711 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2022 | — |
| −2 | K223447 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung | 2023 | — |
| −1 | K233767 | OmniTom Elite | Neurologica Corporation | 2024 | — |
| 0 (this device) | K250928 | OmniTom Elite with PCD | Neurologica Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K233767 | OmniTom EliteSummary page 5…ed Tomography X-ray System Product Code: JAK Device Classification: Class II (per 21 CFR § 892.1750) Predicate Device: 510(k): K233767 Trade Name: OmniTom Elite Device Model: NL5000 Classification Name: Computed Tomography X… | 2024 |
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 30 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K233767.
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. 2025, 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 OmniTom Elite with PCD computed tomography (CT) system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.
The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast. The PCD CT system has multi-energy CT functionality with spectral capability for material decomposition and virtual monoenergetic images (VMI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250928 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250928: OmniTom Elite with PCD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250928
Report an extraction error
Are you the manufacturer?
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