# K230732: Eagle S/Saevo Slim/D700 Slim

- Pathway: 510(k) (Traditional)
- Applicant: Alliage S/A Industrias Medica Odontológico.
- Decided: Apr 11, 2023 after 26 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: 3 generations back to K021718 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162585: SuniIQ Digital Radiography System, Suni Medical Imaging, Inc. (2016) Summary page 4.

## Indications for use
The Intraoral Dental Digital Imaging Sensor is aimed at the acquisition of intra-oral medical images from teeth, jaw and oral structure, only for exclusive dental use and must be handled by trained and qualified health professionals.

Source page: https://510kreport.com/device/K230732
Methodology: https://510kreport.com/methodology