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510(k) Data Aggregation
K Number
K234108Device Name
ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)
Manufacturer
Energy Resources International Co., Ltd.
Date Cleared
2024-09-20
(268 days)
Product Code
IZL
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
Energy Resources International Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ERI Portable X-ray System is a portable x-ray source with a fixed tube current and voltage for producing x-ray images of extremities using computed radiography (CR) detection plate or digital radiography (DR) detector, and the applicable objects are adults. This product is for use by qualified personnel.
It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.
Device Description
ERI Portable X-ray System generates and controls X-ray with a fixed tube current and voltage (kV). It uses X light source to produce X-ray images of human anatomical structures for diagnosis, and the applicable objects are adults. It operates on 14.4VDC supplied by a rechargeable Lithium-Ion Polymer battery pack.
The ERI Portable X-ray System, is a portable x-ray device that comes in three models: CVX-air, CVX-lite and CVX-E. The differences is as follows:
X-ray tube voltage: CVX-air 70kV, CVX-lite 67 kV, CVX-E 60 kV
X-ray tube current: CVX-air 1mA, CVX-lite 0.8mA, CVX-E 0.6mA
Power Consumption: CVX-air 70 W, CVX-lite 53.6 W, CVX-E 36W
Others are the same as CVX-air
The main model and series models have the same internal and external appearance, only the X-ray irradiation parameter settings are different
The X-ray tube head, X-ray controls and power source are assembled in a portable case. The ERI Portable X-ray System is comprised of the following components:
- (1) X-ray module
- (2) Oscillating circuit board
- (3) Control board
- (4) Beam limiting device
- (5) LCD screen
- (6) Extension wire control
- (7) rechargeable battery.
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K Number
K213282Device Name
ERI Handheld Dental X-ray System (Model AG100)
Manufacturer
Energy Resources International Co., Ltd. Hsinchu Branch
Date Cleared
2022-04-04
(185 days)
Product Code
EHD, MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Energy Resources International Co., Ltd. Hsinchu Branch
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ERI Handheld Dental X-Ray System (Model AG100) is intended for the purpose of using it for both adult and pediatric patients by qualified operators (e.g. dentist and/ or radiographer, etc.) regulated by competent authority of each country for producing diagnostic dental X-ray images.
Device Description
It can be used with computed radiography (CR) detection film, digital radiography (DR) detection film or traditional film (dental film) to take intraoral X-rays and provide the information needed by the dentist for diagnosis. As a preoperative, intraoperative, and postoperative evaluation for identifying dental caries or auxiliary root canal treatment, as well as confirming the position of the implant during dental implant surgery. It can take pictures of the front and back teeth, as well as the bite of the back teeth. Applicable objects include adults and children. Due to the medical software included in radiation-emitting device. ERI handheld system is of Moderate level of concern.
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