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ScanX 10

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031198

by Air Techniques, Inc.

Identifiers

510(k) Number
K031198 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 ScanX 10 is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed for digital radiography. It captures high-resolution radiographic images using a flat-panel detector, enabling clear visualization of internal structures for diagnostic purposes in radiology.

This device is intended for use in radiology settings and is supplied as a reusable medical instrument. It operates within Class II regulatory classification under FDA 510(k) clearance (K031198) and adheres to MRI safety standards as defined by regulation number 892.1680. The imager is compatible with intraoral formats and integrates with digital imaging systems for efficient workflow.

Frequently asked questions

What types of medical settings is the ScanX 10 designed for, and how does it integrate with existing workflows?

The ScanX 10 is specifically designed for radiology settings, where high-resolution imaging of internal structures is required. It functions as a Solid State X-Ray Imager (Flat Panel/Digital Imager), meaning it replaces traditional film-based systems by capturing digital images directly. This device is compatible with intraoral formats and integrates seamlessly with digital imaging systems, streamlining workflows by eliminating the need for film processing and reducing turnaround time for diagnostic images.

Is the ScanX 10 a single-use or reusable device, and what maintenance considerations should be taken into account?

The ScanX 10 is supplied as a reusable medical instrument, meaning it is intended for repeated use within a clinical setting. Since it is reusable, proper cleaning, disinfection, and maintenance protocols must be followed to ensure durability, sterility, and optimal imaging performance. The manufacturer’s guidelines (not provided here) should be consulted for specific cleaning and sterilization instructions to prevent contamination and maintain functionality.

What regulatory approvals does the ScanX 10 hold, and how does this affect its use in clinical practice?

The ScanX 10 holds FDA 510(k) clearance (K031198), which means it has been deemed substantially equivalent to a legally marketed device in its category. This clearance confirms that the device meets safety and effectiveness standards for use in radiology. Additionally, it adheres to MRI safety standards (regulation number 892.1680), ensuring compatibility with environments where MRI procedures are performed. Clinicians can rely on this approval to confirm the device’s regulatory compliance for diagnostic imaging.

How does the ScanX 10 differ from traditional film-based X-ray systems, and what advantages does it offer?

Unlike traditional film-based X-ray systems, the ScanX 10 is a digital flat-panel imager, which eliminates the need for chemical processing of film. This transition to digital imaging offers several advantages: instant image review, reduced radiation exposure due to optimized imaging techniques, and enhanced image clarity for better diagnostic accuracy. Additionally, digital storage and transmission of images improve workflow efficiency and accessibility for radiologists.

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 Manuals - Air Techniques, ScanX Intraoral View - Air Techniques, Air Techniques Scanx 10 - allmed.wiki, Air techniques ScanX Intraoral Manuals | ManualsLib, ScanX Brochure - Air Techniques - PDF Catalogs | Technical Documentation

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) K031198 24 fields · synced Sep 18, 2026