Search Results
Found 1 results
510(k) Data Aggregation
K Number
K201800Device Name
Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)
Manufacturer
Date Cleared
2020-12-28
(181 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
NANORAY Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Portable Dental X-Ray (Model: NP-350E) is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.
Device Description
Portable Dental X-ray (Model: NP-350E) is a super capacitor-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing either film or digital imaging techniques. The Portable Dental X-ray Device is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner's office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable super capacitor to allow for the use of the Portable Dental X-ray Device where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility.
The Portable Dental X-ray Device is an X-ray device with a DC generator. The handheld device features a main unit (tube head), charger AC/DC power supply. The power is supplied by a rechargeable super capacitor built into a device. This facilitates portability of the device. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient.
To make the system as simple as possible for the operator, Portable Dental X-ray Device uses a fixed tube voltage of 70kV and a fixed tube current of 3.5mA. The only operator-adjustable parameter is the exposure time. This adjustment can be quickly accomplished through the user-friendly control panel.
Control buttons, display, and a trigger provide the primary operator interface. Exposures settings can be selected and displayed. Voltage (70 kV) and current (3.5 mA) are fixed with the exposure time varying based on patient type, detector type, and anatomical feature. Exposures can be completed using the trigger. The device can be used with three detector types: film, digital imaging intraoral sensors, and phosphor plates.
Ask a Question
Ask a specific question about this device
Page 1 of 1