6 results
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12ms
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Sources: EU EUDAMED, US FDA
Pentacam HR REF 70900. Used to image the anterior segment of the eye.
FDA Enforcement
Class II
·Ongoing·Oculus Optikgeraete GMBH·September 7, 2022
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
FDA Enforcement
Class II
·Ongoing·Oculus Optikgeraete GMBH·September 7, 2022
Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
FDA Enforcement
Class II
·Ongoing·Oculus Optikgeraete GMBH·September 7, 2022
Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses and contact lenses.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 23, 2020
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and lens of the eye, to evaluate corneal shape, analyze condition of the lens (opaque crystalline lens), analyze the anterior chamber angle, analyze anterior chamber depth, analyze the volume of the anterior chamber, analyze anterior or posterior cortical opacity, analyze the location of cataracts (nuclear, sub capsular and/or cortical), using cross slit imaging with densitometry, corneal thickness, axial length, and white-to-white distance. The Pentacam AXL also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.
FDA Enforcement
Class II
·Terminated·Oculus Optikgeraete GMBH·February 28, 2018
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·September 25, 2024