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ADX6000 Portable X-Ray System +1 more model

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K143494

by Dexcowin Co., Ltd.

Identifiers

510(k) Number
K143494 FDA 510(k)
FDA Product Code
IZL FDA 510(k)
Models / Variants
ADX6000 Portable X-Ray System FDA 510(k)EUDAMED
iRayA6 FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1720 FDA 510(k)
Regulation Number
892.1720 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ADX6000 Portable X-Ray System; iRay A6 is a mobile X-ray imaging device designed for general radiography applications. It employs a variable X-ray tube to produce high-quality radiographic images, suitable for both intraoral and extraoral examinations across various anatomical regions.

This system is intended for use in clinical settings, including hospitals, dental offices, and emergency medical environments. It is supplied as a reusable device, with no indication of sterility requirements in the provided data. The system is classified as Class II under FDA regulations and has received FDA 510(k) clearance and MDD authorization. No specific MRI safety information or size specifications are noted in the available documentation.

Frequently asked questions

What clinical environments is the ADX6000 Portable X-Ray System designed to be used in, and why is portability important for these settings?

The ADX6000 Portable X-Ray System is designed for use in hospitals, dental offices, and emergency medical environments. Portability is critical in these settings because it allows for imaging to be performed at the patient’s bedside or in areas where a stationary X-ray machine would be impractical, such as emergency rooms or intensive care units. This flexibility ensures timely diagnostics without requiring patient transfer.

Is the ADX6000 Portable X-Ray System intended for single-use or reusable applications, and what does this mean for maintenance and cleaning?

The ADX6000 Portable X-Ray System is explicitly described as a reusable device. This means it is designed for repeated use across multiple patients, requiring proper cleaning, disinfection, and maintenance protocols to ensure safety, functionality, and compliance with clinical hygiene standards. Reusability also implies a longer lifespan and lower per-use cost compared to single-use devices.

What types of X-ray examinations can the ADX6000 Portable X-Ray System perform, and how does its variable X-ray tube contribute to image quality?

The ADX6000 is suitable for both intraoral (e.g., dental) and extraoral (e.g., skeletal, thoracic) radiographic examinations across various anatomical regions. Its variable X-ray tube allows for adjustable imaging parameters, enabling high-quality radiographs tailored to different tissue densities and examination requirements, which enhances diagnostic accuracy and versatility.

How is the ADX6000 Portable X-Ray System regulated, and what does the Class II designation imply about its oversight?

The ADX6000 has received FDA 510(k) clearance and MDD authorization, confirming regulatory compliance. As a Class II device under FDA regulations, it undergoes stricter scrutiny than Class I but less than Class III. This classification implies it poses moderate risk and requires special controls—such as performance standards, post-market surveillance, or labeling requirements—to ensure safety and effectiveness in clinical use.

Are there any specific storage requirements for the ADX6000 Portable X-Ray System, particularly given its reusable nature and portability?

While the provided data does not specify sterility requirements, the reusable nature of the ADX6000 implies it must be stored in a clean, dry environment when not in use to prevent contamination or damage. Since it is portable, storage should also account for ease of transport while protecting components from physical stress or environmental factors that could compromise functionality or hygiene.

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: DEXCOWIN | adx6000fb, DEXCOWIN IRAYA6 USER MANUAL Pdf Download | ManualsLib, Dexcowin iRay A6 Digital Handheld Dental X-ray ADX6000FB, ADX6000 Portable X-Ray System; iRayA6 - fda.innolitics.com

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dexcowin Co., Ltd.

Sources (2)

  • FDA 510(k) K143494 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026