510(k) · Cleared
ClearedBodyTom 64 (NL4100); OmniTom Elite (NL5000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samsung HME America, Inc., dba NeuroLogica Corp. · JAK System, X-Ray, Tomography, Computed
Cleared on Sep 22, 2026 as substantially equivalent to K242811 (Neurologica Corporation, A Subsidiary of Samsung, 2025) and 1 other predicate after a 169-day review. Its family tree reaches back 11 generations to 1995. 1 of the 34 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 22, 2026
- Review
- 169 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K944131 (1995). 33 ancestors in all, the oldest K780395 (1978). No later device cites it as a predicate yet. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 7 generations between
- 3 generations backK170238 BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017
- 2 generations backK213649 BodyTom 64Neurologica Corporation · 2022
- 1 generation backK242811 BodyTom 64Neurologica Corporation, A Subsidiary of Samsung · 2025
- This deviceK261125 BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026
Show all 11 generations
- Root · 11 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 10 generations backK964890 Anatom 2000Analogic Corp. · 1997
- 9 generations backK982631 Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998
- 8 generations backK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
- 7 generations backK014240 ProntoHitachi Medical Systems America, Inc. · 2002
- 6 generations backK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · Recalled
- 5 generations backK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled
- 4 generations backK102677 Bodytom NL 4000Neurologica Corporation · 2011
- 3 generations backK170238 BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017
- 2 generations backK213649 BodyTom 64Neurologica Corporation · 2022
- 1 generation backK242811 BodyTom 64Neurologica Corporation, A Subsidiary of Samsung · 2025
- This deviceK261125 BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026
Class I recalls in this family
- K962738 Millennium MT and Millennium MG Nuclear Medicine…7 generations back · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| −10 | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| −9 | K982631 | Philips Tomoscan CS | Philips Medical Systems, Inc. | 1998 | — |
| −8 | K991278 | Philips Tomoscan AV-NT | Philips Medical Systems North America, Inc. | 1999 | — |
| −7 | K014240 | Pronto | Hitachi Medical Systems America, Inc. | 2002 | — |
| −6 | K040902 | Hitachi Presto | Hitachi Medical Systems America, Inc. | 2004 | 4 |
| −5 | K071806 | Eclos Computed Tomography X-Ray System | Hitachi Medical Systems America, Inc. | 2007 | 1 |
| −4 | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
| −3 | K170238 | BodyTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2017 | — |
| −2 | K213649 | BodyTom 64 | Neurologica Corporation | 2022 | — |
| −1 | K242811 | BodyTom 64 | Neurologica Corporation, A Subsidiary of Samsung | 2025 | — |
| 0 (this device) | K261125 | BodyTom 64 (NL4100); OmniTom Elite (NL5000) | Samsung HME America, Inc., dba NeuroLogica Corp. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1992 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 1 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K242811 | BodyTom 64Summary page 5…oduct Code: JAK Device Classification: Class II (per 21 CFR § 892.1750) Predicate Device Trade Name: BodyTom 64 (K242811) Classification Name: Computed Tomography X-ray System Product Code: JAK Device Classification… | 2025 |
| * | K233767 | OmniTom EliteSummary page 6…Samsung HME America, Inc. Page 1 of 11 Reference Device Trade Name: OmniTom Elite (K233767) Classification Name: Computed Tomography X-ray System Product Code: JAK Device Classification: C… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K962738Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996 · 7 generations back · ◆ in the 1996 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 31 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- 8 of the 33 ancestors have a recall of any class; 1 has a Class I recall.
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. 2026, 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 BodyTom 64 system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture. 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. BodyTom 64 system can be used for low dose lung cancer screening. The screening must be performed in compliance with…
Read the full statement (187 words)
The BodyTom 64 system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture. 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. BodyTom 64 system can be used for low dose lung cancer screening. The screening must be performed in compliance with the approved and established protocols as defined by professional medical societies.
*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
The OmniTom Elite computed tomography (CT) system is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 40cm aperture, primarily the 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/K261125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261125: BodyTom 64 (NL4100); OmniTom Elite (NL5000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261125
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026