# K162585: SuniIQ Digital Radiography System

- Pathway: 510(k) (Traditional)
- Applicant: Suni Medical Imaging, Inc.
- Decided: Nov 4, 2016 after 49 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- 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 K021718 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070219: Suniray II Digital Radiography System, Suni Medical Imaging, Inc. (2007) Summary page 4.

## Most influential descendants
- K230732: Eagle S/Saevo Slim/D700 Slim (2023), 0 descendants of its own

## Indications for use
The SuniIQ Digital Radiography system is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

Source page: https://510kreport.com/device/K162585
Methodology: https://510kreport.com/methodology