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Scanx 14

FDA 510(k)

Class II (US FDA 510(k))

510(k) K042397

by Air Techniques, Inc.

Identifiers

510(k) Number
K042397 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 14 is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed for high-resolution digital radiography. It captures and digitizes radiographic images from both intraoral and extraoral formats, including sizes 0–4 and Pan/Ceph plates, enabling advanced diagnostic imaging in radiology settings.

This system is supplied as a reusable medical device, intended for use in radiology departments or clinical environments. It features an in-line erase function for image processing and is compatible with standard radiographic film formats. The device is classified as Class II under FDA regulations (892.1680) and holds an FDA 510(k) clearance (K042397) for special review in radiology applications. Storage and handling follow standard medical imaging protocols to ensure image integrity and device longevity.

Frequently asked questions

What types of radiographic images can the ScanX 14 capture and digitize, and how does this benefit clinical workflows?

The ScanX 14 is designed to capture and digitize both intraoral and extraoral radiographic images, including sizes 0–4 and Pan/Ceph plates. This versatility allows radiology departments to consolidate imaging workflows by using a single device for multiple formats, reducing the need for separate systems and streamlining diagnostic processes.

Is the ScanX 14 intended for single-use or reusable applications, and what maintenance features does it include?

The ScanX 14 is supplied as a reusable medical device, which means it is designed for repeated use in clinical settings. It includes an in-line erase function for image processing, ensuring that residual images do not interfere with subsequent scans, which helps maintain image integrity and device longevity.

What compatibility considerations should clinicians keep in mind when using the ScanX 14 with existing radiographic film formats?

The ScanX 14 is explicitly compatible with standard radiographic film formats, meaning it can be integrated into workflows already using these sizes without requiring additional adapters or modifications. This ensures seamless adoption in radiology departments.

How should the ScanX 14 be stored and handled to ensure optimal performance and image quality?

The ScanX 14 follows standard medical imaging protocols for storage and handling, which typically include protecting the device from physical damage, extreme temperatures, and contamination. Proper storage ensures the longevity of the device and maintains the high-resolution imaging quality expected in radiology applications.

What regulatory pathway was followed for the ScanX 14, and how does this affect its use in clinical settings?

The ScanX 14 received FDA 510(k) clearance under special review in radiology applications, classified as a Class II device under FDA regulations (892.1680). This clearance indicates that the device has been evaluated for substantial equivalence to a predicate device and meets FDA safety and performance standards, allowing for its use in radiology departments with confidence in its regulatory compliance.

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, Air Techniques Scanx 14 | allmed.wiki, ScanX Classic View - Air Techniques, PDF Instruction Manual - allpro-imaging.com

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) K042397 24 fields · synced Sep 20, 2026