# K123332: Naomi-CT

- Pathway: 510(k) (Traditional)
- Applicant: Lk Consulting Group
- Decided: Jul 18, 2013 after 265 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- 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: 6 generations back to K973598 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101181: Bel-Cat, Takara Belmont Corp. (2011)
- K070658: Dental Digital Panoramic/3D Imaging System, E-Woo Technology (2007)

## Indications for use
The NAOMI-CT is used to lake three- and two-dimensional x-ray images for the detection of dental abnormalities for a purpose of examination and diagnosis of diseases of the teeth, jaw, and oral structures..

Source page: https://510kreport.com/device/K123332
Methodology: https://510kreport.com/methodology