Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Diagnostic X-Ray Equipment Model POCT22

K-Number: K252909 · 2026-02-03

ApplicantNingbo Runyes Medical Instrument Co., Ltd.
Decision Date2026-02-03
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Diagnostic X-Ray Equipment Model POCT22 is a medical device manufactured by Ningbo Runyes Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-02-03 under approval number K252909. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diagnostic X-Ray Equipment Model POCT22?

Diagnostic X-Ray Equipment Model POCT22 is a medical device that received FDA 510(k) clearance on 2026-02-03. It is manufactured by Ningbo Runyes Medical Instrument Co., Ltd.. The 510(k) number is K252909.

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

Diagnostic X-Ray Equipment Model POCT22 received FDA 510(k) clearance on 2026-02-03, under approval number K252909.

What company makes Diagnostic X-Ray Equipment Model POCT22?

Diagnostic X-Ray Equipment Model POCT22 is manufactured by Ningbo Runyes Medical Instrument Co., Ltd..

What is the FDA product code for Diagnostic X-Ray Equipment Model POCT22?

The FDA product code for Diagnostic X-Ray Equipment Model POCT22 is EHD.

Related Clinical Trials

NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT06292299 The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study RECRUITING NCT07263815 EQUIP - Evaluation of Quality of Imaging on a Next-generation Total Body Pet Scan in Comparison to Conventional PET ACTIVE_NOT_RECRUITING NCT07506967 Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers NOT_YET_RECRUITING NCT07073430 Application Evaluation Research on the Artificial Intelligence-assisted Support System for the Diagnosis of Colorectal Tubular Adenoma Lesions RECRUITING

Related PubMed Literature

PMID: 41513582 Medical devices for professional use: What assessment, what funding? Therapie (2026)

Other Devices by Ningbo Runyes Medical Instrument Co., Ltd.

K231449Portable X-ray System Model Ray98(P)

Related Devices (Code: EHD)

K161063EzRay Air (Model VEX-P300)VATECH Co., Ltd. K160458BI IMAGE-X EVOLUTIONRadiotecnologia Industrial S.A. DE C.V. K173319KaVo NOMAD Pro 2 Handheld X-ray SystemAribex K170967Intraskan DC PlusSkanray Technologies Private Limited K163705EzRay Air WVATECH Co., Ltd. K163519RX DCCefla S.C.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑