Search Results

The Konan Specular Microscope XVII, CellChek 20, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.

The Konan Specular Microscope XVII, CellChek 20, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea. Cell counting and analysis program are included, and allow for analysis of the images of the cell distribution of the eye. When photographing the corneal endothelium, the device performs the alignment and automatically focuses by capturing the reflected light from patient's eye with the camera. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, as well as computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory and can be preserved by using a printer. The parts of the device that come into contact with a patient are the forehead rest and the chin rest. Their material is acrylonitrile butadiene styrene (ABS), the same material used in reference device and one with proven biocompatibility. The function of the software installed in the device is to calculate mainly the cell density, the coefficient of variation of cell area and the percent hexagonality. In the manual methods, Actual identification if the cells and cell boundaries is done by the (physician) user. In the automatic method, the software detects the cells and cell boundaries, however, the user is given the opportunity to make corrections. In use, the user interacts with the software by visually placing dots in the center of cells as or by tracing cell boundaries as they appear or on a screen or uses the automatic algorithm.

The NIDEK Specular Microscope CEM-530 is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.

The NIDEK Specular Microscope CEM-530 which is the subject of this 510(k) is a modification to the NIDEK Specular Microscope CEM-530 cleared in K151706. The only change to the cleared device is to the software which has been revised to improve the accuracy of the automated analysis method. All other aspects of the cleared device remain unchanged. The NIDEK Specular Microscope CEM-530 provides non-contact. high magnification image capture of the endothelium enabling observation of the size and shape of cells. Information such as the corneal endothelial cell density(CD), the coefficient of variation of corneal endothelial cell area (CV), % hexagonality of cells (%HEX), is analyzed through the captured images. The captured images and analysis results of the endothelium are used to assist in intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the Center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection. In addition to the specular microscopy, the corneal thickness can be optically measured in a non-contact method. The CEM-530 has auto-tracking and auto-shooting functions. Results can be printed using the the built-in thermal printer or captured images can be transferred to a filing system via LAN connection.

The EM-4000 Specular Microscope is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.

The Tomey EM-4000 Specular Microscope is a non-contact ophthalmic microscope and camera intended for corneal endothelium imaging. Its operating principle is based on the Specular optical principle. This device is used for imaging the corneal endothelium. The EM-4000 analyzes and displays data such as cell number, cell density, coefficient of variation and percent hexagonality. When photographing the corneal endothelium, the equipment performs the alignment and automatically focuses by capturing the reflected light from the patient's eye with the CCD camera. Infrared LEDs are used as the light source for the alignment. Operation with the iovstick also makes it possible to focus manually. The green LED light radiates to the cornea, and the endothelium image is captured with the CCD camera by the reflected light from the cornea. The endothelium images are stored in internal memory. Furthermore, the EM-4000 is able to measure the central corneal thickness. The corneal endothelium is photographed first followed by measuring the central corneal thickness. The infrared LED light for measurement of corneal thickness radiates to the cornea through the objective lens for photographing the cornea, and the central corneal thickness can be calculated by measuring the distance on the optical line sensor between the reflected light from front surface and back surface of cornea.

The Specular Microscope CEM-530 is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.

The Nidek Specular Microscope CEM-530 provides non-contact, high magnification image capture of the endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of the endothelium are used in intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection. In addition to the specular microscopy, the corneal thickness can be optically measured in a non-contact method. The CEM-530 has auto-tracking and auto-shooting functions. Results can be printed using the built-in thermal printer or captured images can be transferred to a filing system via LAN connection. The Specular Microscope CEM-530 cleared in this 510(k) is identical to the Specular Microscope CEM-530 cleared in K130565 with the addition of a new analysis mode: Center Point Method. All other aspects of the cleared device remain unchanged.

The Specular Microscope SP-1P is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea.

This instrument is a photographic device dedicated to photograph and record corneal endothelial cells as an electronic image without contacting the eye. The Specular Microscope SP-1P also allows for measuring corneal thickness at the same time as corneal endothelial cells photography. The Specular Microscope SP-1P has functions that permit users to analyze photographed corneal endothelial cells and to calculate the area and form of corneal endothelial cells. It automatically performs alignment, photography and analysis. The Specular Microscope SP-1P contains multiple fixation targets, and allows users to photograph both central and peripheral corneal endothelial cells depending upon which fixation target is used. The Specular Microscope SP-1P has a manual image alignment function which allows the operator to utilize the internal function of the SP-1P to focus on the cornea and obtain the image. The manual image alignment can be utilized in difficult lighting or cases where the subject has a difficult time fixating. The Specular Microscope SP-1P also has a manual editing function which allows the clinician to modify the cells selected on the automatically captured image. Photographed images, images for observation and analysis results are displayed on the color LCD monitor with touch panel. An internal printer allows for printing photographed images and analysis results.

The Nidek Specular Microscope CEM-530 is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.

The Nidek Specular Microscope CEM-530 provides non-contact, high magnification image capture of the endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of the endothelium are used in intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection. In addition to the specular microscopy, the corneal thickness can be optically measured in a non-contact method. The CEM-530 has auto-tracking and auto-shooting functions. Results can be printed using the the built-in thermal printer or captured images can be transferred to a filing system via LAN connection.

The Konan Specular Microscope XIV, Cellchek Plus, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.

The Konan Specular Microscope XIV, CellChek Plus, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. Cell counting and analysis programs are included, and allow for analysis of the cell distribution of the eye (the same analysis software present in the predicate device is also present in the modified device). When photographing the corneal endothelium, the equipment performs the alignment and automatically focuses by capturing the reflected light from the patient's eye with the CCD camera. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory, and are preserved by using a printer. Both the image of the corneal endothelium and the various computerized control functions are displayed on the touch screen. The parts of the device that come into contact with a patient are the forehead rest and the chin rest. The head rest is comprised of Polytetrafluoroethylene (PTFE), which is known as Teflon®, and the material that comprises the chin rest is Acrylonitrile butadiene styrene (ABS).

The Noncon Robo Pachy F&A is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea.

The Noncon Robo Pachy F&A specular microscope and optical pachymeter is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. It is an improvement to the original Konan Noncon Robo Pachy, K980357. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photographic images are temporarily stored in the system's memory, and are preserved in video form on magnetic tape or by using a video printer. The memory can store two endothelial cell images and two anterior segment images, which are usually those of the left and right eyes.

The Konan Kerato Analyzer ("EKA") is a specular microscope used to make cell counts of preserved corneas in eye banks and to measure the thicknesses of the corneas without removing the corneas from their storage vials.

The Konan Kerato Analyzer ("EKA") is a specular microscope used to make cell counts of prescrved corneas in eye banks and to measure the thicknesses of the corneas without removing the corneas from their storage vials. The basic structure of the EKA is similar to that of an inverted laboratory microscope. With the EKA, all focusing is done manually by the operator. For the EKA, vials containing the corneas are placed in a receptacle in the unit.