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Vinno E20, Vinno E10, Vinno E10p, Vinno E10e, Vinno X1, Vinno X1e, Vinno X1p, V…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K223917

by Vinno Technology (Suzhou) Co., Ltd

Identifiers

510(k) Number
K223917 FDA 510(k)
FDA Product Code
IYN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1550 FDA 510(k)
Regulation Number
892.1550 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The VINNO E20, E10, E10P, E10E, X1, X1E, X1P, X2, X2E, and X2P are digital radiography detectors designed for use in radiographic imaging systems. These devices convert X-ray exposure into digital signals, enabling high-resolution imaging for diagnostic purposes in radiology settings.

Supplied as reusable components, these detectors are intended for integration into radiographic imaging systems and are regulated under the FDA’s 510(k) pathway with a Substantially Equivalent determination. They are classified under product code IYN and comply with the Medical Device Regulation (MDR) framework, ensuring adherence to safety and performance standards for radiographic imaging equipment.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vinno Technology (Suzhou) Co., Ltd
FDA Applicant
Vinno Technology (Suzhou) Co.,Ltd

Sources (2)

  • FDA 510(k) K223917 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 26, 2026