The devices is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray…
The devices is a hand-held diagnostic dental x-ray system. It 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. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The system helps to get sharp and clear x-ray images, and its low radiation dosage keeps patients and dentists safe from leakage radiation.
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (2), Zhejiang (2).
Record
Regulatory record for XTG V | 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.