Air Techniques High Frequency Intra-Oral X-Ray
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111330 FDA 510(k)
- FDA Product Code
- EHD 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 Air Techniques High Frequency Intra-Oral X-Ray is a unit that provides an extraoral source of X-rays for dental radiography. It is classified as a Unit, X-ray, Extraoral With Timer and is designed for diagnostic imaging in dental applications.
This device is supplied by Skanray Technologies and received FDA 510(k) clearance on May 27, 2011. It is a Class II device with special controls and is intended for use as an extraoral X-ray source in dental diagnostic radiography. The system includes two microprocessors for control and user interface functions.
Frequently asked questions
What is the Air Techniques High Frequency Intra-Oral X-Ray used for?
It is designed as an extraoral source of X-rays for dental radiography, providing diagnostic imaging in dental applications by emitting X-rays from outside the mouth to capture intraoral images.
How is the Air Techniques High Frequency Intra-Oral X-Ray supplied and what are its key components?
It is supplied by Skanray Technologies as a complete unit that includes two microprocessors for control and user interface functions, enabling operation of the extraoral X-ray source with timer functionality.
Is the Air Techniques High Frequency Intra-Oral X-Ray a single-use or reusable device?
It is a reusable dental X-ray unit intended for repeated use in clinical settings, as it is a hardware system with electronic controls and not a disposable or single-use component.
What regulatory pathway was used for the Air Techniques High Frequency Intra-Oral X-Ray?
It received FDA 510(k) clearance on May 27, 2011, under submission K111330, and is classified as a Class II device with special controls for dental extraoral X-ray imaging.
What are the storage and handling considerations for the Air Techniques High Frequency Intra-Oral X-Ray?
While specific storage conditions are not detailed in the provided data, as a medical electrical device it should be stored in a clean, dry environment according to the manufacturer’s instructions to maintain functionality and safety.
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: AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY (K111330) — FDA 510(k ..., K111330 - Air Techniques High Frequency Intra-oral X-ray, PDF SA~IJtRAV Air Techniques High Frequency Intra-Oral X-Ray TECHOLOIES
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111330 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Skanray Technologies
Sources (1)
- FDA 510(k) K111330 24 fields · synced Sep 21, 2026