510(k) · Cleared
ClearedCeretom, Model NL3000
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 Jul 14, 2005 as substantially equivalent to K964890 (Analogic Corp., 1997) and 2 other predicates after a 14-day review. Its family tree reaches back 2 generations to 1995. 27 later devices descend from it.
- Decided
- Jul 14, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K944131 (1995). 6 ancestors in all, the oldest K941546 (1994). 27 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 1 generation backK964890 Anatom 2000Analogic Corp. · 1997
- This deviceK051765 Ceretom, Model NL3000Neurologica Corporation · 2005
- Descendant · cites it directly · 10 of its ownK090811 Inspira HD, Model: NL1000Neurologica Corporation · 2009
- Descendant · cites it directly · 9 of its ownK102677 Bodytom NL 4000Neurologica Corporation · 2011
- Descendant · cites it directly · 6 of its ownK171183 OmniTomNeurologica Corporation · 2017 · Recalled
- Descendant · cites it directly · 6 of its ownK061834 Xcat; Xcat for NeuroXoran Technologies, Inc. · 2006
- Descendant · 2 generations on · 5 of its ownK202526 OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2020 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K090811Inspira HD, Model: NL1000Neurologica Corporation · 2009 · cites it directly10descendants
- K102677Bodytom NL 4000Neurologica Corporation · 2011 · cites it directly9descendants
- K171183OmniTomNeurologica Corporation · 2017 · cites it directly6descendants
- K061834Xcat; Xcat for NeuroXoran Technologies, Inc. · 2006 · cites it directly6descendants
- K202526OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2020 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| −1 | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| 0 (this device) | K051765 | Ceretom, Model NL3000 | Neurologica Corporation | 2005 | — |
| +1 | K090811 | Inspira HD, Model: NL1000 | Neurologica Corporation | 2009 | — |
| +1 | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
| +1 | K171183 | OmniTom | Neurologica Corporation | 2017 | 2 |
| +1 | K061834 | Xcat; Xcat for Neuro | Xoran Technologies, Inc. | 2006 | — |
| +2 | K202526 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2020 | 1 |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K964890 | Anatom 2000Summary page 2…ivalencies are being claimed are as follows: * Philips Tomoscan M/EG CT. This predicate device was cleared under pre- market Notification K964890. * GE LightSpeed Ultra CT. This predicate device was cleared under pre- market Notification K000300… | 1997 |
| * | K000300 | Lightspeed 2.0CT Scanner SystemSummary page 2…under pre- market Notification K964890. * GE LightSpeed Ultra CT. This predicate device was cleared under pre- market Notification K000300 * Siemens SOMATOM Plus 4 with sliding Gantry Option. This predicate device was cleared under pre-market… | 2000 |
| * | K991600 | Somatom Plus 4 with Sliding Gantry OptionSummary page 2…market Notification K000300 * Siemens SOMATOM Plus 4 with sliding Gantry Option. This predicate device was cleared under pre-market Notification K991600 (4) Device Description: The NL3000 CereTom is a high resolution, 8 row, 32 cm bore, 25cm field of view, Compute… | 1999 |
What descends from it? (27)
See all 276 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K090811 (Neurologica Corporation, 2009) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K964890.
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.
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 NL3000 CereTom is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 25cm field of view, primarily head and neck.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051765: Ceretom, Model NL3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051765
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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