Cleared Traditional

Cocoon Solo (DX-7020s)

K250687 · Dexcowin Global, Inc. · Radiology

Oct 2025

Decision

232d

Days

Class 2

Risk

About This 510(k) Submission

K250687 is an FDA 510(k) clearance for the Cocoon Solo (DX-7020s), a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Dexcowin Global, Inc. (Pasadena, US). The FDA issued a Cleared decision on October 24, 2025, 232 days after receiving the submission on March 6, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K250687 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2025
Decision Date	October 24, 2025
Days to Decision	232 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF