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The Dental High-speed Turbine Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector.
The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only.
Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization).
In order to avoid the risk, user must buy and use specified lubricant type “PANA SPRAY Plus” manufactured by NAKANISHI INC (cleared in K163483).
Guangdong JINME Medical Technology Co., Ltd.
T, S, TU, SU, TP, SP, TUQ, TUP, SUP, SUQ, TUQP, SUQP
In Commercial Distribution
- 06971119540012 ()
- Dental power tool system handpiece, pneumatic
The Algometer provides pain diagnostic testing with digital clarity and computer interface for data logging.
The AlgoMed Computerized Pressure Algometry is an Algometry device including advanced software package designed for clinical use and advance research in the field of Pain Management.
The AlgoMed enables the user to perform various pressure test paradigms including the method of limits and the ramp and hold method. These test paradigms can be utilized for a wide range of pressure pain measures such as pressure pain threshold and tolerance, temporal summation, DNIC and more. The device can also evaluate disease or treatment progress over time.
MEDOC LTD.
FPIX
In Commercial Distribution
- 07290103039554 ()
- 07290103039059 ()
AS 00300
- Pressure algesimeter
To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes). The device is intended use in licensed practitioner’s office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by practitioner.
LD TECHNOLOGY, LLC
D001
In Commercial Distribution
- B322D0011 ()
- Pulse oximeter, line-powered
Molemate is a software management system for the SIAScope that displays five unique views: dermatoscopic, blood supply, pigment, dermal pigment and collagen.The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as ‘Spectrophotometric Intracutaneous Analysis’ (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin’s interior structure.The SIAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit.
MedX Health Corp
V
In Commercial Distribution
- 00628451918004 ()
- 00628451918035 ()
- 10628451918032 ()
- Skin transilluminator, battery-powered
The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as ‘Spectrophotometric Intracutaneous Analysis’ (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin’s interior structure.The SIAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit. Simsys is an image management system for the Siascope , which in addition to the features of the Molemate software, includes mole and lesion visualization and comprehensive patient image and data storage capabilities.
MedX Health Corp
V
In Commercial Distribution
- 00628451918073 ()
- 00628451918004 ()
- 10628451918070 ()
- Skin transilluminator, battery-powered
The Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece, for the model LN and L. The device description of the Dental Low-speed Handpiece is as following:
The gear ratios of handpieces have various gear ratios (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 1:5 (speed increase));
The handpieces have maximum Forward rotation speed 19000 rpm and maximum Reverse rotation speed of 18000 rpm.
The air motors are capable of running up to a speed of 22000 rpm, but different at different pressure of air supply; refer to section 2.3 for details.
The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only.
Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization).
Guangdong JINME Medical Technology Co., Ltd.
LN, L
In Commercial Distribution
- 06971119540029 ()
- Dental power tool system handpiece, pneumatic
The NIDEK Optical Coherence Tomography RS-3000 Advance is an ophthalmic camera that allows non-invasive and non-contact observation of the shape of the fundus or retina. Fundus surface images (hereafter referred to as SLO image) are captured with the confocal laser scanning using a near-infrared light source with a wavelength of 785 nm. Cross-sectional images of the retina (hereafter referred to as OCT image) are captured with the optical interferometer using an infrared light source with a wavelength of 880 nm. With the images captured using the RS-3000 Advance, the shape and structure of the fundus or retina can be observed, and diseases can be observed. This system is comprised of the main body for capturing images, a computer (hereafter called PC) for storing and analyzing captured images, PC monitor, and an isolation transformer.
In addition, the image filing software NAVIS-EX (hereafter referred to as NAVIS-EX) offers the following features:
• Image analysis functions such as 3D/map color display or retinal thickness analysis
• Networking for data review or analysis on PCs in separate locations
NIDEK CO.,LTD.
RS-3000 Advance
In Commercial Distribution
- 04987669100516 ()
- Direct ophthalmoscope, line-powered
The Saccadometer Adavnced system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Advanced is equipped with three red laser projectors with 10º separation and green laser located centrally over the red. Eighteen experiments are included in embedded software.
The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage.
Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
OBER CONSULTING SP Z O O
ADVANCED
In Commercial Distribution
- 05906874392027 ()
- Eye movement analysis system
The Saccadometer Plus system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Plus is equipped with three red laser projectors with 10º separation, and 6 experiments are included in embedded software.
The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage.
Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
OBER CONSULTING SP Z O O
PLUS
In Commercial Distribution
- 05906874392010 ()
- Eye movement analysis system