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Scanx D5000 Series Scanner Model: D5000-F, D5000-Fb, D5000-Fvb, D5000-Q, D5000-…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101289

by Air Techniques, Inc.

Identifiers

510(k) Number
K101289 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 D5000 Series Scanner is a solid-state X-ray imager (flat panel/digital imager) designed for digital radiography. It captures high-resolution intraoral and extraoral radiographic images using digital detector technology, enabling precise diagnostic imaging for dental and medical applications.

These scanners are intended for use in radiology settings and are supplied as reusable medical devices. They are classified as Class II devices under FDA regulations (892.1680) and have received FDA 510(k) clearance through a traditional review process. Each model variant is engineered for specific imaging requirements, with no indication of single-use or sterility requirements in the regulatory data.

Frequently asked questions

What types of imaging does the ScanX D5000 Series Scanner support, and how does it differ between the models?

The ScanX D5000 Series Scanner is designed for digital radiography, capturing high-resolution images for both intraoral (inside the mouth) and extraoral (outside the mouth) applications. While the exact differences between the models (D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB) are not detailed in the provided data, the series is engineered for specific imaging requirements—likely tailored for dental and medical radiology settings. The solid-state digital detector technology ensures precise diagnostic imaging across these use cases.

Is the ScanX D5000 Series Scanner intended for single-use or reusable applications?

The ScanX D5000 Series Scanner is explicitly described as a reusable medical device. There are no indications in the regulatory data suggesting single-use or sterility requirements, so it is designed for repeated use in clinical settings after proper cleaning and maintenance.

What regulatory pathway was followed for FDA clearance of the ScanX D5000 Series Scanner?

The ScanX D5000 Series Scanner received FDA 510(k) clearance through a traditional review process, meaning the manufacturer demonstrated that it is substantially equivalent to a legally marketed device already on the market. The device is classified under FDA classification 892.1680 as a Class II medical device, with the Radiology advisory committee overseeing its submission.

Are there specific storage or handling instructions for the ScanX D5000 Series Scanner?

While the provided data does not specify exact storage instructions, as a reusable medical device, proper handling is critical. The scanner should be stored in a clean, dry environment to prevent damage or contamination. Since it is not labeled as sterile, it must undergo cleaning and disinfection protocols as required by clinical practice before reuse. Always follow manufacturer guidelines for maintenance and storage.

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 Bluetooth OBD2 Scanner - Lifetime CarScanner Pro App

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) K101289 24 fields · synced Sep 18, 2026