# K051765: Ceretom, Model NL3000

- Pathway: 510(k) (Traditional)
- Applicant: Neurologica Corporation
- Decided: Jul 14, 2005 after 14 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944131 (1995). 6 ancestors in all.
27 later devices descend from it; 6 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964890: Anatom 2000, Analogic Corp. (1997) Summary page 2.
- K000300: Lightspeed 2.0CT Scanner System, Ge Medical Systems, Inc. (2000) Summary page 2.
- K991600: Somatom Plus 4 with Sliding Gantry Option, Siemens Corp. (1999) Summary page 2.

## Most influential descendants
- K090811: Inspira HD, Model: NL1000 (2009), 10 descendants of its own
- K102677: Bodytom NL 4000 (2011), 9 descendants of its own
- K171183: OmniTom (2017), 6 descendants of its own
- K061834: Xcat; Xcat for Neuro (2006), 6 descendants of its own
- K202526: OmniTom Elite (2020), 5 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K051765
Methodology: https://510kreport.com/methodology