Portable X-ray System Model Ray98(P)— 510(k) K231449

Name: FDA 510(k) clearance K231449
Creator: U.S. Food and Drug Administration
Published: 2023-07-13

Substantially Equivalent

Ningbo Runyes Medical Instrument Co., Ltd.

FDA 510(k) clearance K231449 for Portable X-ray System Model Ray98(P), Substantially Equivalent on 2023-07-13. Applicant: Ningbo Runyes Medical Instrument Co., Ltd.. Device class: 2.

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: 2023-05-18
Decision date: 2023-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo, CN

Download summary PDF View on FDA.gov ↗

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