# K220574: Hybrid S70

- Pathway: 510(k) (Traditional)
- Applicant: Digimed Co., Ltd.
- Decided: Apr 22, 2022 after 53 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- 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: 7 generations back to K000061 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132041: Rextar X, Meta Biomed, Inc. (2013) Summary page 4.

## Indications for use
HYBRID S70 is intended to be used by trained dentists and dental technicians as a portable and a mobile, extra-oral X-ray source. This can help producing diagnostic x-ray images by using with various intra-oral image detectors. This x-ray image can be used for dental examination (diagnosis) before or after treatment. Its use is intended for both adult and pediatric subjects.

Source page: https://510kreport.com/device/K220574
Methodology: https://510kreport.com/methodology