510(k) · Cleared
Recalled · Class II · 2023OmniTom Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurologica Corporation, A Subsidiary of Samsung Electronics · JAK System, X-Ray, Tomography, Computed
Cleared on Dec 23, 2020 as substantially equivalent to K171183 (Neurologica Corporation, 2017) after a 113-day review. Its family tree reaches back 4 generations to 1995. 5 later devices descend from it. It has been recalled once.
- Decided
- Dec 23, 2020
- Review
- 113 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K944131 (1995). 8 ancestors in all, the oldest K941546 (1994). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 3 generations backK964890 Anatom 2000Analogic Corp. · 1997
- 2 generations backK051765 Ceretom, Model NL3000Neurologica Corporation · 2005
- 1 generation backK171183 OmniTomNeurologica Corporation · 2017 · Recalled
- This deviceK202526 OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2020
- Descendant · cites it directly · 4 of its ownK211711 OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2022
- Descendant · 2 generations on · 3 of its ownK223447 OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung · 2023
- Descendant · 3 generations on · 2 of its ownK233767 OmniTom EliteNeurologica Corporation · 2024
- Descendant · 4 generations on · 0 of its ownK261125 BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026
- Descendant · 4 generations on · 0 of its ownK250928 OmniTom Elite with PCDNeurologica Corporation · 2025
Most influential descendants
Showing 5 of 5 · See all- K211711OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2022 · cites it directly4descendants
- K223447OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung · 2023 · 2 generations on3descendants
- K233767OmniTom EliteNeurologica Corporation · 2024 · 3 generations on2descendants
- K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026 · 4 generations on0descendants
- K250928OmniTom Elite with PCDNeurologica Corporation · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| −3 | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| −2 | K051765 | Ceretom, Model NL3000 | Neurologica Corporation | 2005 | — |
| −1 | K171183 | OmniTom | Neurologica Corporation | 2017 | 2 |
| 0 (this device) | K202526 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2020 | — |
| +1 | K211711 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2022 | — |
| +2 | K223447 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung | 2023 | — |
| +3 | K233767 | OmniTom Elite | Neurologica Corporation | 2024 | — |
| +4 | K261125 | BodyTom 64 (NL4100); OmniTom Elite (NL5000) | Samsung HME America, Inc., dba NeuroLogica Corp. | 2026 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K171183 | OmniTomSummary page 4…raphy X-ray System Product Code: JAK Device Classification: Class II (per 21 CFR § 892.1750) Predicate Device Trade Name: OmniTom (K171183) Classification Name: Computed Tomography X-ray System Product Code: JAK Device Classification: Clas… | 2017 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211711 | OmniTom Elite | 2022 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 6, 2023 | Class II | Z-2068-2023 | Process design | 1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K211711 (Neurologica Corporation, A Subsidiary of Samsung Electronics, 2022) has gone furthest, with 4 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. 2020, 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 CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40cm field of view, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202526: OmniTom Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202526
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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