510(k) · Cleared
ClearedBodytom NL 4000
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 Mar 24, 2011 as substantially equivalent to K051765 (Neurologica Corporation, 2005) and 2 other predicates after a 190-day review. Its family tree reaches back 7 generations to 1995. 1 of the 34 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Mar 24, 2011
- Review
- 190 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K944131 (1995). 24 ancestors in all, the oldest K780395 (1978). 9 later devices descend from it, 3 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 6 generations backK964890 Anatom 2000Analogic Corp. · 1997
- 5 generations backK982631 Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998
- 4 generations backK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
- 3 generations backK014240 ProntoHitachi Medical Systems America, Inc. · 2002
- 2 generations backK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · Recalled
- 1 generation backK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled
- This deviceK102677 Bodytom NL 4000Neurologica Corporation · 2011
- Descendant · cites it directly · 4 of its ownK170238 BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017
- Descendant · 2 generations on · 2 of its ownK213649 BodyTom 64Neurologica Corporation · 2022
- Descendant · cites it directly · 2 of its ownK131431 Airo CT SystemMobius Imaging, LLC · 2013 · Recalled
- Descendant · 3 generations on · 1 of its ownK242811 BodyTom 64Neurologica Corporation, A Subsidiary of Samsung · 2025
- Descendant · 2 generations on · 1 of its ownK160126 AIRO Computed Tomography (CT) X-ray SystemMobius Imaging · 2016 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K962738 Millennium MT and Millennium MG Nuclear Medicine…3 generations back · 1996
Most influential descendants
Showing 5 of 9 · See all- K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017 · cites it directly4descendants
- K213649BodyTom 64Neurologica Corporation · 2022 · 2 generations on2descendants
- K131431Airo CT SystemMobius Imaging, LLC · 2013 · cites it directly2descendants
- K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung · 2025 · 3 generations on1descendant
- K160126AIRO Computed Tomography (CT) X-ray SystemMobius Imaging · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| −6 | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| −5 | K982631 | Philips Tomoscan CS | Philips Medical Systems, Inc. | 1998 | — |
| −4 | K991278 | Philips Tomoscan AV-NT | Philips Medical Systems North America, Inc. | 1999 | — |
| −3 | K014240 | Pronto | Hitachi Medical Systems America, Inc. | 2002 | — |
| −2 | K040902 | Hitachi Presto | Hitachi Medical Systems America, Inc. | 2004 | 4 |
| −1 | K071806 | Eclos Computed Tomography X-Ray System | Hitachi Medical Systems America, Inc. | 2007 | 1 |
| 0 (this device) | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
| +1 | K170238 | BodyTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2017 | — |
| +2 | K213649 | BodyTom 64 | Neurologica Corporation | 2022 | — |
| +1 | K131431 | Airo CT System | Mobius Imaging, LLC | 2013 | 1 |
| +3 | K242811 | BodyTom 64 | Neurologica Corporation, A Subsidiary of Samsung | 2025 | — |
| +2 | K160126 | AIRO Computed Tomography (CT) X-ray System | Mobius Imaging | 2016 | 2 |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K051765 | Ceretom, Model NL3000Summary page 2…valence is being claimed is as follows: " NeuroLogica Corporation, NL3000 Cere''omTM CT- per Pre-Market Notification Submission K05 1765 " Hitachi Medical Systems America, Inc. ELCOSI6TM - per Pro-Market Notification Submission K07 1806… | 2005 |
| * | K071806 | Eclos Computed Tomography X-Ray SystemSummary page 2…-Market Notification Submission K05 1765 " Hitachi Medical Systems America, Inc. ELCOSI6TM - per Pro-Market Notification Submission K07 1806 " NeuroLogica Corporation, inSPira HDTM - per Pre-Market Notification Submission K090811I (4) Device D… | 2007 |
| * | K090811 | Inspira HD, Model: NL1000Summary page 2…- per Pro-Market Notification Submission K07 1806 " NeuroLogica Corporation, inSPira HDTM - per Pre-Market Notification Submission K090811I (4) Device Description: 'Lhc NL4000 BodyTom is essentially a larger bore version of our predicate NL3000 CereTom… | 2009 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 24 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170238 (Neurologica Corporation, A Subsidiary of Samsung Electronics, 2017) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K051765.
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. 2011, 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 NL4000 BodyTom is intended to be used for x-ray Computed Tomography applications for anatomy that can be imaged in the 85cm aperture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102677: Bodytom NL 4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102677
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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