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Portable X-Ray System, Models DIOX-602, PROX

FDA 510(k)

Class II (US FDA 510(k))

510(k) K082167

by Digimed Corporation

Identifiers

510(k) Number
K082167 FDA 510(k)
FDA Product Code
EHD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.1800 FDA 510(k)
Regulation Number
872.1800 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Portable X-Ray System, models DIOX-602 and PROX, is an extraoral X-ray unit equipped with a timer. It is designed to capture diagnostic images for dental applications.

This device is a Class 2 medical device that has received FDA 510(k) clearance. It is intended for use in professional dental settings to facilitate extraoral radiographic imaging.

Frequently asked questions

What is the primary use of the DIOX-602 and PROX systems?

These units are designed for use in professional dental settings to facilitate extraoral radiographic imaging for diagnostic purposes.

What is the regulatory status of these portable X-ray systems?

The DIOX-602 and PROX are classified as Class 2 medical devices and have received FDA 510(k) clearance under the regulation number 872.1800.

What features are included in these portable X-ray units?

Both the DIOX-602 and PROX models are extraoral X-ray units that come equipped with an integrated timer to assist in capturing diagnostic images.

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 (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Digimed Corporation

Sources (1)

  • FDA 510(k) K082167 24 fields · synced Sep 23, 2026