# K250687: Cocoon Solo (DX-7020s)

- Pathway: 510(k) (Traditional)
- Applicant: Dexcowin Global, Inc.
- Decided: Oct 24, 2025 after 232 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 K133007 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173046: Cocoon Portable Handheld X-Ray System, Dexcowin Co., Ltd. (2017) Summary page 5.

## Indications for use
Cocoon Solo (DX-7020s) is a portable x-ray system indicated for taking diagnostic dental x-rays for both pediatric and adult patients.

Source page: https://510kreport.com/device/K250687
Methodology: https://510kreport.com/methodology