510(k) · Cleared
ClearedBodyTom 64
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 Apr 29, 2022 as substantially equivalent to K170238 (Neurologica Corporation, A Subsidiary of Samsung Electronics, 2017) after a 161-day review. Its family tree reaches back 9 generations to 1995. 1 of the 29 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Apr 29, 2022
- Review
- 161 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K944131 (1995). 26 ancestors in all, the oldest K780395 (1978). 2 later devices descend from it, 1 citing it directly. 1 of the 29 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 5 generations between
- 3 generations backK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled
- 2 generations backK102677 Bodytom NL 4000Neurologica Corporation · 2011
- 1 generation backK170238 BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017
- This deviceK213649 BodyTom 64Neurologica Corporation · 2022
- Descendant · cites it directly · 1 of its ownK242811 BodyTom 64Neurologica Corporation, A Subsidiary of Samsung · 2025
- Descendant · 2 generations on · 0 of its ownK261125 BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026
Show all 9 generations
- Root · 9 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 8 generations backK964890 Anatom 2000Analogic Corp. · 1997
- 7 generations backK982631 Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998
- 6 generations backK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
- 5 generations backK014240 ProntoHitachi Medical Systems America, Inc. · 2002
- 4 generations backK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · Recalled
- 3 generations backK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled
- 2 generations backK102677 Bodytom NL 4000Neurologica Corporation · 2011
- 1 generation backK170238 BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017
- This deviceK213649 BodyTom 64Neurologica Corporation · 2022
Class I recalls in this family
- K962738 Millennium MT and Millennium MG Nuclear Medicine…5 generations back · 1996
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 |
|---|---|---|---|---|---|
| −9 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| −8 | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| −7 | K982631 | Philips Tomoscan CS | Philips Medical Systems, Inc. | 1998 | — |
| −6 | K991278 | Philips Tomoscan AV-NT | Philips Medical Systems North America, Inc. | 1999 | — |
| −5 | K014240 | Pronto | Hitachi Medical Systems America, Inc. | 2002 | — |
| −4 | K040902 | Hitachi Presto | Hitachi Medical Systems America, Inc. | 2004 | 4 |
| −3 | K071806 | Eclos Computed Tomography X-Ray System | Hitachi Medical Systems America, Inc. | 2007 | 1 |
| −2 | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
| −1 | K170238 | BodyTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2017 | — |
| 0 (this device) | K213649 | BodyTom 64 | Neurologica Corporation | 2022 | — |
| +1 | K242811 | BodyTom 64 | Neurologica Corporation, A Subsidiary of Samsung | 2025 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (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 |
|---|---|---|---|
| * | K170238 | BodyTom EliteSummary page 5…750) 1 K213649 Predicate Device Trade Name: BodyTom Elite (K170238) Classification Name: Computed Tomography X-ray System Product Code: JAK Device Classification:… | 2017 |
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 |
|---|---|---|---|
| K242811 | BodyTom 64 | 2025 | 1 |
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 · 5 generations back · ◆ in the 1996 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 6 of the 26 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K242811 (Neurologica Corporation, A Subsidiary of Samsung, 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K170238.
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. 2022, 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 NL4100 BodyTom 64 CT 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 CT system can be used for low dose lung cancer screening. The screening must be performed in…
Read the full statement (121 words)
The NL4100 BodyTom 64 CT 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 CT 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213649: BodyTom 64.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213649
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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