← Back to catalogue

myray ProXIma X6

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K252353

by CEFLA s.c.

Identifiers

510(k) Number
K252353 FDA 510(k)
FDA Product Code
OAS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The myray ProXIma X6 is a Computed Tomography, Dental device, classified as a Class II medical device under FDA regulations. It is designed for high-resolution imaging of dental structures, enabling detailed cross-sectional views for diagnostic and treatment planning purposes in radiology.

This device is supplied as a reusable, non-sterile system intended for use in dental radiology settings. It operates under FDA 510(k) clearance and MDR authorization, adhering to strict regulatory standards for computed tomography applications. The system includes multiple FEI numbers (e.g., 3009717300, 3012957335) and is intended for professional use by trained operators in controlled environments.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
CEFLA s.c.

Sources (2)

  • FDA 510(k) K252353 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026