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ScanX Digital X-Ray System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K013893

by Air Techniques, Inc.

Identifiers

510(k) Number
K013893 FDA 510(k)
FDA Product Code
MUH 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 ScanX Digital X-Ray System is a digital extraoral X-ray imaging device designed for dental applications. It captures high-resolution radiographic images of the jaw, teeth, and surrounding structures, enabling precise diagnostic assessments for dental professionals. The system integrates digital technology to enhance imaging efficiency and accuracy in oral health evaluations.

This device is intended for use in dental offices, clinics, and specialized dental facilities. Supplied as a reusable, non-sterile system, it requires proper handling and maintenance per manufacturer guidelines. The ScanX operates within Class II (21 CFR 872.1800) regulatory classification and holds an FDA 510(k) clearance under the Traditional pathway. Multiple model variants are available, each corresponding to specific registration numbers and FEI identifiers for traceability.

Frequently asked questions

What types of dental imaging does the ScanX Digital X-Ray System provide, and why is this important for dental diagnostics?

The ScanX Digital X-Ray System specializes in capturing high-resolution radiographic images of the jaw, teeth, and surrounding oral structures. This extraoral imaging is critical for dental diagnostics because it allows for precise assessment of dental anatomy, identification of issues like impacted teeth, bone abnormalities, or pathologies that may not be visible through intraoral imaging alone. The digital format also enhances efficiency and accuracy in evaluating oral health conditions.

Is the ScanX system reusable, and if so, what maintenance or handling guidelines should be followed?

Yes, the ScanX is supplied as a reusable system, meaning it is not single-use. Since it is non-sterile, proper handling and maintenance are essential to ensure consistent performance and prevent contamination. Users must follow the manufacturer’s guidelines for cleaning, calibration, and upkeep to maintain imaging quality and comply with regulatory requirements.

How do I determine which model variant of the ScanX system is right for my dental practice?

The ScanX system comes in multiple model variants, each associated with specific registration numbers and FEI identifiers (e.g., 3000190675, 3038718579, etc.). These identifiers are tied to traceability and regulatory compliance. To select the right model, consult the manufacturer’s documentation or contact Air Techniques, Inc. directly—they can guide you based on your practice’s needs, such as imaging volume, workflow requirements, or compatibility with existing systems.

What regulatory pathway was followed for FDA clearance of the ScanX, and what does this mean for my practice?

The ScanX received FDA clearance through the Traditional 510(k) pathway, which means it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance confirms that the device meets FDA safety and effectiveness standards for dental extraoral X-ray imaging. For your practice, this indicates that the device has undergone rigorous review and is approved for use in dental offices, clinics, and specialized facilities as intended.

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: ScanX Classic View - Air Techniques, ScanX Intraoral View - Air Techniques, ScanX Brochure - Air Techniques - PDF Catalogs | Technical Documentation, Air techniques ScanX Intraoral Manuals | ManualsLib

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Air Techniques, Inc.

Sources (1)

  • FDA 510(k) K013893 24 fields · synced Sep 20, 2026