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ScanX Touch/ScanX Duo Touch

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191623

by Air Techniques, Inc.

Identifiers

510(k) Number
K191623 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 Touch and ScanX Duo Touch are digital extraoral X-ray systems designed for dental imaging. They utilize phosphor storage plates (PSPs) to capture high-resolution images of dental structures, supporting intraoral formats ranging from size 0 to size 4. These systems are classified as digital X-ray systems with extraoral sources, enabling efficient and precise radiographic imaging for diagnostic purposes in dentistry.

These devices are intended for use in dental offices, clinics, and academic settings. The ScanX Touch features a single scanning slot, while the ScanX Duo Touch includes dual slots for simultaneous scanning of PSPs, enhancing workflow efficiency. Supplied as reusable medical devices, they are not sterile and require proper handling and maintenance. The systems are FDA-cleared under the 510(k) pathway as substantially equivalent to predicate devices, with a classification of Class II (MUH product code). No MRI safety information is specified.

Frequently asked questions

What types of dental images can the ScanX Touch/ScanX Duo Touch capture, and how does the dual-slot feature improve workflow efficiency?

The ScanX Touch and ScanX Duo Touch systems are designed to capture high-resolution images of dental structures using phosphor storage plates (PSPs) in intraoral formats ranging from size 0 to size 4. The dual-slot feature of the ScanX Duo Touch allows for simultaneous scanning of two PSPs, which significantly reduces processing time and improves workflow efficiency in busy dental offices or clinics.

Are the ScanX Touch and ScanX Duo Touch systems reusable, and what considerations should be taken into account when handling them?

Yes, the ScanX Touch and ScanX Duo Touch are supplied as reusable medical devices. Since they are not sterile, proper handling and maintenance are essential to ensure optimal performance and hygiene. Users should follow manufacturer guidelines for cleaning, disinfection, and routine maintenance to prevent contamination and extend the device’s lifespan.

How does the regulatory pathway for the ScanX Touch/ScanX Duo Touch differ from other dental imaging devices, and what does this mean for clinicians?

The ScanX Touch and ScanX Duo Touch were cleared by the FDA under the 510(k) pathway, specifically classified as substantially equivalent to predicate devices. This means the FDA determined they meet the same performance standards as existing digital extraoral X-ray systems, ensuring they are safe and effective for dental imaging. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though they should still follow the manufacturer’s instructions for proper use and maintenance.

What environments are these devices intended for, and how might the choice between the ScanX Touch and ScanX Duo Touch impact a practice’s decision?

These systems are intended for use in dental offices, clinics, and academic settings. The ScanX Touch is ideal for smaller practices or single-user workflows due to its single scanning slot, while the ScanX Duo Touch’s dual slots make it better suited for high-volume environments where efficiency is critical, such as larger clinics or multi-provider offices.

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 Duo Touch - Air Techniques, ScanX Duo Touch - Air Techniques, Air Techniques ScanX Duo Touch | Henry Schein Catalog, Air Techniques ScanX Duo Touch Image Plate Scanner

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) K191623 24 fields · synced Sep 20, 2026