Address:5300 Central Parkway,DUBLIN,CA,94568,US
Device Description : The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographicand biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging ofposterior ocular structures.
Device Class : 2
Duns Number: 362747011
Premarket Exempt : No
Prescription Use : No
Device Description : The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicrosco The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior and posterior ocular structures. The device is indicated for visualizing and measuring anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The CIRRUS normative databases are quantitative tools indicated for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiformlayer thickness, and optic nerve head measurements to a database of normal subjects. The CIRRUS OCT Angiography is indicated as an aid in the visualization of vascular structures ofthe retina and choroid. The CIRRUS HD-OCT is indicated as a diagnostic device to aid in thedetection and management of ocular diseases including, but not limited to, macular holes,cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.
Device Class : 2
Duns Number: 362747011
Premarket Exempt : Yes
Prescription Use : No
Device Description : The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscop The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imagining of anterior and posterior ocular structures.
Device Class : 2
Duns Number: 362747011
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The CLARUS 500 is an active, non-contact, software controlled, high resolution i The CLARUS 500 is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye. The CLARUS 500 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view.
Device Class : 2
Duns Number: 362747011
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CLARUS 700 is an active, non-contact, software controlled, high resolution i The CLARUS 700 is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye.The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view.The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and the choroid.
Device Class : 2
Duns Number: 362747011
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CLARUS is an active, non-contact, software controlled, high resolution imagi The CLARUS is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye. The CLARUS ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS Review Software can be installed on a separate review station (PC or laptop) for data review and analysis.
Device Class : 2
Duns Number: 362747011
Premarket Exempt : No
Prescription Use : Yes