acteongroup.comDHX-70H, XTG-70H
Digimed Co., Ltd.
DIGIMED CO., LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007933232 | 3007933232 | DIGIMED CO., LTD | 1 | N | 2026-01-01 | 401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu Seoul KR 08505 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 08800021800113 | xm-lite - The portable x-ray system, HYBRID C70 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. | (800) 289-6367 | michele.bottino@acteongroup.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 123141 | 1489708023 | K221587 | DHX-70H, XTG-70H | EHD | 2023-03-03 |
| 123141 | 1005461043 | K220579 | Hybrid C70 | EHD | 2022-09-01 |
| 123141 | 2041549541 | K220574 | HYBRID S70 | EHD | 2022-04-22 |
| 123141 | 1815020518 | K181891 | Portable X-ray System (Model: MiniX-V, Mini X-S) | EHD | 2018-08-10 |
| 123141 | 2015855207 | K152859 | Portable X-ray System (Model: MINIX-V / MINIX-S) | EHD | 2015-12-03 |
| 123141 | 1711388031 | K103600 | PORTABLE X-RAY SYSTEM | EHD | 2011-04-08 |
| 123141 | 2002252655 | K082167 | PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX | EHD | 2008-09-26 |
| 123141 | 1934213033 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| EHD | 7 | 2023-03-03 |
PMN#
Hybrid C70
Digimed Co., Ltd
HYBRID S70
Digimed Co., LTD.
Portable X-ray System (Model: MiniX-V, Mini X-S)
Digimed Co., LTD.
Portable X-ray System (Model: MINIX-V / MINIX-S)
DIGIMED CO., LTD. (DIGIMED CORPORATION UNTIL 31/12/2012)
GUDID#
XTG - 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.
2026-06-01
XTG V - 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.
2026-06-01
xm-lite - The portable x-ray system, HYBRID C70 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.
2022-12-01
BIOX - The portable x-ray system, BIOX 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.
2024-06-12
HYBRID S70 - The portable x-ray system, HYBRID S70 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.
2024-06-12
XTG PRO 70 - 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.
2024-06-12
DHX-70H - The portable x-ray system, DHX-70H 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.
2024-06-12
BIOX - The portable x-ray system, BIOX 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.
2024-06-12
HYBRID S70 - The portable x-ray system, HYBRID S70 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.
2024-06-12
XTG PRO 70 - 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.
2024-06-12
DHX-70H - The portable x-ray system, DHX-70H 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.
2024-06-12
PROX - The PROX 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.
2016-11-07
PROX - The PROX 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.
2016-11-07
DIOX-602 - The DIOX-602 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.
2016-11-07
xm-lite - The portable x-ray system, HYBRID C70 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.
2022-12-01
MiniX-S - The MiniX-S 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.
2018-01-19
MiniX-V - The MiniX-V 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.
2016-11-07
MiniX-S - The MiniX-S 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.
2018-01-19
MiniX-V - The MiniX-V 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.
2016-11-07