Diagnostic X-Ray Equipment Model POCT22

FDA 510(k) K252909 · Ningbo Runyes Medical Instrument Co., Ltd.

Substantially Equivalent

510(k) numberK252909

Submission

Device name
Diagnostic X-Ray Equipment Model POCT22
Applicant
Ningbo Runyes Medical Instrument Co., Ltd.
Ningbo Zhejiang, CN
Received
September 12, 2025
Decision date
February 3, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EHD – Unit, X-Ray, Extraoral With Timer
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Specialty
Dental

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Questions and answers

When was Diagnostic X-Ray Equipment Model POCT22 cleared by the FDA?

Diagnostic X-Ray Equipment Model POCT22 (K252909) received a 510(k) decision of Substantially Equivalent on February 3, 2026, 144 days after the submission was received.

What is the product code of K252909?

The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.