# K102677: Bodytom NL 4000

- Pathway: 510(k) (Traditional)
- Applicant: Neurologica Corporation
- Decided: Mar 24, 2011 after 190 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: 7 generations back to K944131 (1995). 24 ancestors in all.
9 later devices descend from it; 3 cite it directly.
1 of 34 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051765: Ceretom, Model NL3000, Neurologica Corporation (2005) Summary page 2.
- K071806: Eclos Computed Tomography X-Ray System, Hitachi Medical Systems America, Inc. (2007) Summary page 2.
- K090811: Inspira HD, Model: NL1000, Neurologica Corporation (2009) Summary page 2.

## Most influential descendants
- K170238: BodyTom Elite (2017), 4 descendants of its own
- K213649: BodyTom 64 (2022), 2 descendants of its own
- K131431: Airo CT System (2013), 2 descendants of its own
- K242811: BodyTom 64 (2025), 1 descendant of its own
- K160126: AIRO Computed Tomography (CT) X-ray System (2016), 1 descendant of its own

## Indications for use
The NL4000 BodyTom is intended to be used for x-ray Computed Tomography applications for anatomy that can be imaged in the 85cm aperture.

Source page: https://510kreport.com/device/K102677
Methodology: https://510kreport.com/methodology