Diagnostic X-Ray Equipment Model POCT22— 510(k) K252909
Substantially EquivalentNingbo Runyes Medical Instrument Co., Ltd.
FDA 510(k) clearance K252909 for Diagnostic X-Ray Equipment Model POCT22, Substantially Equivalent on 2026-02-03. Applicant: Ningbo Runyes Medical Instrument Co., Ltd.. Device class: 2.
Summary
Ningbo Runyes Medical Instrument's Diagnostic X-Ray Equipment Model POCT22 is filed under product code EHD (Unit, X-Ray, Extraoral With Timer). The record doesn't describe the equipment beyond its name and that code name.
Class II, 21 CFR 872.1800. The Radiology review panel handled it as a Traditional 510(k), though the record lists Dental as the classification panel.
Ningbo Runyes Medical Instrument filed from Ningbo Zhejiang, China. Review took 144 calendar days (September 12, 2025 to February 3, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Ningbo Runyes Medical Instrument Co., Ltd.
- Product code
- Product code EHD
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ningbo Zhejiang, CN
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