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EXPD 4343P, EXPD 3643P

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K193031

by DRTECH Corporation

Identifiers

510(k) Number
K193031 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 EXPD 4343P and EXPD 3643P are Solid State X-Ray Imagers (Flat Panel/Digital Imagers), classified under product code MQB. These devices convert X-ray exposure into digital signals, enabling high-resolution radiographic imaging for diagnostic purposes in radiology.

These imagers are intended for use in stationary X-ray systems and are supplied as reusable medical devices. They comply with 21 CFR 892.1680 and have received FDA 510(k) clearance and MDR authorization. The devices are designed for integration into radiology settings, adhering to regulatory standards for Class II medical devices under special controls.

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: EXPD 4343P, EXPD 3643P (K193031) — FDA 510(k) | Innolitics, K193031 FDA 510 (k) - EXPD 4343P | DRTECH Corporation, Drtech Expd 4343P, Expd 3643P - allmed.wiki, EXPD 4343P, EXPD 3643P (K193031) — FDA 510(k) | Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
DRTECH Corporation

Sources (2)

  • FDA 510(k) K193031 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026