Portable Dental X-ray Device (GT-1)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K254018 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 Portable Dental X-ray Device (GT-1) is a dental x-ray device with a timer, used for extraoral imaging. It is a portable device, designed to be compact and lightweight. The device features an exposure trigger and a Type C connection, and it has fast charging capabilities.
The device is supplied as a single unit and is intended for use in dental applications. It has received FDA 510(k) clearance, with the clearance number K254018. The device is classified as a class 2 device, with the regulation number 872.1800. It is designed for use in a dental setting, and its storage and use should follow standard protocols for dental x-ray devices.
Frequently asked questions
What is the GT-1 Portable Dental X-ray Device used for?
The GT-1 is used for extraoral imaging in dental applications, providing a compact and lightweight solution for dental x-ray needs.
Is the GT-1 Portable Dental X-ray Device supplied as a single unit?
Yes, the GT-1 is supplied as a single unit, making it a convenient and self-contained solution for dental x-ray imaging.
What type of connection does the GT-1 Portable Dental X-ray Device have?
The GT-1 features a Type C connection, allowing for easy and convenient use in dental settings.
Has the GT-1 Portable Dental X-ray Device received any regulatory clearances?
Yes, the GT-1 has received FDA 510(k) clearance, with the clearance number K254018, indicating its substantial equivalence to existing devices.
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: GT-1 Portable X-Ray Gun, Dental Xray Gun Imaging Unit|Refine Medical, Portable Dental X-ray Device (GT-1) (K254018) - Innolitics, Portable Dental X-ray Device (GT-1) - FDA 510(k) K254018, K254018 FDA 510 (k) - Portable Dental X-ray Device (GT-1), Portable Dental X-ray Device (GT-1) - FDA 510(k) K254018
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K254018 | Class II | Active |
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Manufacturer
- Manufacturer
- Guilin Refine Medical Instrument Co., Ltd.
Sources (1)
- FDA 510(k) K254018 24 fields · synced Oct 6, 2026