Cleared Traditional

Diagnostic X-Ray Equipment Model POCT22

K252909 · Ningbo Runyes Medical Instrument Co., Ltd. · Radiology

Feb 2026

Decision

144d

Days

Class 2

Risk

About This 510(k) Submission

K252909 is an FDA 510(k) clearance for the Diagnostic X-Ray Equipment Model POCT22, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Ningbo Runyes Medical Instrument Co., Ltd. (Ningbo Zhejiang, CN). The FDA issued a Cleared decision on February 3, 2026, 144 days after receiving the submission on September 12, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K252909 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 2025
Decision Date	February 03, 2026
Days to Decision	144 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF