Accent Digital Extraoral X-Ray System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050693 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 Accent is a digital extraoral X-ray system designed for dental radiography. It employs an X-ray source to capture high-resolution images of dental structures, including panoramic and cephalometric views, aiding in diagnostic assessments for dental professionals.
This system is intended for use in dental offices and clinics, providing reusable components with a focus on dental imaging. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance. The system operates with specific X-ray tube head configurations and is not intended for MRI environments. Storage and maintenance follow manufacturer guidelines to ensure optimal performance and safety.
Frequently asked questions
What types of dental images can the Accent system capture, and how does this benefit dental professionals?
The Accent system is designed to capture high-resolution extraoral dental images, including panoramic and cephalometric views. These imaging modalities provide comprehensive visualizations of dental structures, jaw alignment, and overall facial anatomy, which are critical for diagnosing complex dental conditions, planning orthodontic treatments, and evaluating growth patterns in pediatric patients. The digital format also enables faster image processing, easier sharing with specialists, and reduced radiation exposure compared to traditional film-based systems.
Are all components of the Accent system reusable, or are there single-use parts that require replacement after each procedure?
The Accent system is explicitly described as having reusable components, meaning the core imaging hardware—such as the X-ray tube head and detector—is intended for repeated use in dental offices and clinics. Single-use parts, if any, are not mentioned in the provided data, so clinicians should follow the manufacturer’s guidelines for maintenance and replacement schedules to ensure safety and performance.
What storage and maintenance requirements should I consider for the Accent system to ensure optimal performance and longevity?
The Accent system’s storage and maintenance follow manufacturer guidelines, which likely include protecting the device from physical damage, environmental contaminants, and extreme temperatures. Since it is a reusable Class II medical device, regular calibration, cleaning, and inspection of components (such as the X-ray tube head and detector) are essential to maintain image quality and compliance with safety standards. Always refer to Air Techniques’ documentation for specific protocols.
How do I determine which X-ray tube head configuration is compatible with my Accent system, and are there multiple options available?
The Accent system operates with specific X-ray tube head configurations, though the exact models or variations aren’t detailed in the provided data. The system is designed to accommodate multiple configurations, as evidenced by the extensive list of registration numbers tied to its digital extraoral X-ray functionality. Clinicians should consult Air Techniques’ product documentation or support team to identify compatible tube heads for their specific imaging needs, such as panoramic or cephalometric views.
Can the Accent system be used in environments where MRI machines are present, or are there any restrictions on its placement?
The Accent system is explicitly not intended for use in MRI environments. This restriction is likely due to potential interference between the X-ray system’s electronic components and the strong magnetic fields generated by MRI machines. Always ensure the device is placed in a location free from such electromagnetic interference to avoid operational disruptions or safety hazards.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050693 | Class II | Active |
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Manufacturer
- Manufacturer
- Air Techniques, Inc.
Sources (1)
- FDA 510(k) K050693 24 fields · synced Sep 18, 2026