510(k) · Cleared
ClearedNExCT 7
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 Dec 23, 2014 as substantially equivalent to K102677 (Neurologica Corporation, 2011) and 1 other predicate after a 92-day review. Its family tree reaches back 8 generations to 1995. 1 of the 28 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 23, 2014
- Review
- 92 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K944131 (1995). 27 ancestors in all, the oldest K780395 (1978). No later device cites it as a predicate yet. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 7 generations backK964890 Anatom 2000Analogic Corp. · 1997
- 6 generations backK982631 Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998
- 5 generations backK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
- 4 generations backK014240 ProntoHitachi Medical Systems America, Inc. · 2002
- 3 generations backK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · Recalled
- 2 generations backK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled
- 1 generation backK102677 Bodytom NL 4000Neurologica Corporation · 2011
- This deviceK142697 NExCT 7Neurologica Corporation · 2014
Class I recalls in this family
- K962738 Millennium MT and Millennium MG Nuclear Medicine…4 generations back · 1996
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 | K982631 | Philips Tomoscan CS | Philips Medical Systems, Inc. | 1998 | — |
| −5 | K991278 | Philips Tomoscan AV-NT | Philips Medical Systems North America, Inc. | 1999 | — |
| −4 | K014240 | Pronto | Hitachi Medical Systems America, Inc. | 2002 | — |
| −3 | K040902 | Hitachi Presto | Hitachi Medical Systems America, Inc. | 2004 | 4 |
| −2 | K071806 | Eclos Computed Tomography X-Ray System | Hitachi Medical Systems America, Inc. | 2007 | 1 |
| −1 | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
| 0 (this device) | K142697 | NExCT 7 | Neurologica Corporation | 2014 | — |
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 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K102677 | Bodytom NL 4000Summary page 5…ed are as follows: x NeuroLogica Corp., NL4000 BodyTom® Computed Tomography System. This predicate device was cleared under premarket Notification K102677. This is the predicate used for the bulk of comparison of design and labeling. x Toshiba Amer… | 2011 |
| * | K122109 | Aquilion One Vision, V4.90Summary page 5…Toshiba America Medical Systems, Inc., Aquilion ONE Vision, TSX- 301C/1, v4.90. This predicate device was cleared under premarket Notification K122109. This predicate is being used for comparison of detector coverage and rotational speed characteristics. Both… | 2012 |
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 · 4 generations back · ◆ in the 1996 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 8 of the 27 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K102677.
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. 2014, 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 NLS128 [NExCT 7] system is intended to be used for x-ray computed tomography applications that produce cross sectional images for anatomy that can be imaged in the system aperture. The NExCT 7 is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142697: NExCT 7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142697
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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