# K253111: Aeka Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Good Methods Global, Inc.
- Decided: Mar 13, 2026 after 170 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K913770 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210682: SOTA Cloud Imaging, Sota Precision Optics, Inc. Dba Sota Imaging (2021) Summary page 5.

## Indications for use
Aeka Imaging is a clinical software application that provides a web-based interface for image acquisition and image management in the field of Dentistry and operated by dental professionals who are responsible for providing dental care. Aeka Imaging receives patient’s dental images from various dental acquisition devices (for eg. radiographic devices, digital image/video capture devices, generic devices such as scanners). Also, the previously acquired images or volumes can be selected for upload directly from the user's computer. The software is intended to acquire, display, process edit (rotate, flip, resize, change brightness/contrast/gamma), annotate, review, store, print and distribute patient images using standard PC hardware.

Source page: https://510kreport.com/device/K253111
Methodology: https://510kreport.com/methodology