The device is an x-ray generating device which is mainly designed for dental examination. The device has an x-ray tube for generating x-rays, a high voltage transformer for generating high…
The device is an x-ray generating device which is mainly designed for dental examination. The device has an x-ray tube for generating x-rays, a high voltage transformer for generating high voltages, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to low voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, saving and displaying the data, a power P.C.B for supplying power to the circuit and apparatus in housing, user interface (LCD screen) and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patients and users from unnecessary exposure of radiation. The device is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both.
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (2), Zhejiang (2).
Record
Regulatory record for XTG | Listed by | Digimed Co., Ltd., South Korea |
| FDA product code | EHD |
| Device type | Unit, X-Ray, Extraoral With Timer |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| Establishment | Manufacturer |
| 510(k) | K181891 |
| Record published | 2026-06-01 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 40 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 80 to 106 KiloPascal; Handling environment temperature 10 to 35 °C; Handling environment humidity 10 to 85 % RH; Handling environment atmospheric pressure 80 to 106 KiloPascal |
| Packaging | Carton box, carton box of 2, carton box of 3, carton box of 4, carton box of 5, carton box of 6 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.