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MasterX 800 Series

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230918

by Medicatech USA

Identifiers

510(k) Number
K230918 FDA 510(k)
FDA Product Code
MQB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1680 FDA 510(k)
Regulation Number
892.1680 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MasterX 800 Series is a Solid State X-Ray Imager (Flat Panel/Digital Imager) designed for radiology applications. It is a digital radiology solution that provides high image quality with lightweight designs and long-lasting battery power.

The device is supplied as part of a complete digital radiology system and is regulated under FDA 510K clearance with product code MQB. It is intended for use in radiology settings and is manufactured by Medicatech USA in Irvine, California.

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. Sources consulted: MasterX® 800 Series Archives - Medicatech USA®, PDF MasterX 800 Series by Medicatech USA® - ti-ba.com, MasterX 801C 14″x17″ wireless - Medicatech USA®

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medicatech USA

Sources (1)

  • FDA 510(k) K230918 24 fields · synced Sep 27, 2026