The portable x-ray system, HYBRID Pro is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required.…
The portable x-ray system, HYBRID Pro is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (2), Zhejiang (2).
Record
Regulatory record for XTG PRO 70 | 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 |
| Record published | 2024-06-12 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 45 to 90 % RH; Handling environment temperature 21 to 40 °C; Storage environment atmospheric pressure 80 to 106 KiloPascal; Storage environment humidity 5 to 90 % RH; Storage environment temperature -20 to 60 °C |
| 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.