Search Results

The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for: • viewing the posterior segment of the eye, including two- and three- dimensional imaging • cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT) • fundus imaging • fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA) • autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak) • performing measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various ocular diseases, including: • age-related macular degeneration • macular edema • diabetic retinopathy • retinal and choroidal vascular diseases • glaucoma The device is indicated for viewing geographic atrophy. The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid. The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases: • a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects • a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laser-scanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image. A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared super-luminescent diode and a spectral interferometer are used to create the cross-sectional images. The following modifications have been applied to the device subject of this 510(k): - Addition of scan acquisitions for the SPECTRALIS OCT Angiography Module (OCTA) at 250 kHz - Update of the default contrast display setting from 1:4 to 1:2 for the Superficial Vascular Complex (SVC) and the Deep Vascular Complex (DVC) for the acquisition speeds of 125 kHz and 250 kHz

The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and measurement of the axial length. The analysis covers: - · Cornea Thickness - · Anterior Segment o Anterior chamber width, depth, volume and angle parameters o Lens Thickness - · Axial Length

The ANTERION is a diagnostic imaging device for the eye. The technology is based on swept-source optical coherence tomography (SS-OCT) technology. The device itself has two basic component groups: · ANTERION Hardware (Imager/Base) with integrated forehead/ chin rest: The hardware includes imaging hardware (e.g., laser, LEDs, optics, detectors, hardware for spatial encoding) as well as a touch screen. • ANTERION Software (V.1.5) (PC): The ANTERION Software includes the main user interface. The software allows for device control, such as selection of examination(s) and imaging parameter(s). The ANTERION software provides an interface for a Medical Image Management and Processing System. The ANTERION hardware is separated in three parts: the Base (bottom part), the Imager (top part), and the Head Rest (forehead/chin rest). For examinations, the patient places his/her head in the forehead/chin rest. The Head Rest is mechanically and electronically connected to the Base and controlled via a joystick. Within its stand, a stepper motor with additional mechanic parts and a controller board are placed, allowing the operator to move the motorized chin rest up or down for optimally positioning the patients' eye. An external fixation light is mounted at the forehead rest. The Base mainly contains the power supply and PC connection of the device. In the Imager, the components for scanning, signal generation, and signal processing are contained. The operator directly accesses two software modules, which are named AQM (acquisition module) and VWM (viewing module). The AQM allows selecting between examinations. The VWM shows acquired images, parameters, and reports. The ANTERION device contains two imaging modalities, a scanning optical coherence tomography (OCT) modality and an infrared (IR) camera. The OCT modality allows for cross-sectional imaging and biometry, while the IR camera allows for en-face imaging of a patient's eve. The ANTERION device provides four separate software functionalities (Apps) to acquire various imaging and measurements of the anterior segment of the eye: (1) the Imaging App. (2) the Cornea App. (3) the Cataract App and (4) the Metrics App. The Cornea App provides tomographic data and measurements for the patient´s individual corneal geometry and corneal characteristics. The Cornea App provides tomographic data and parameters, such as corneal curvature and thickness. The Cataract App provides key measurements for cataract surgery planning, such as corneal thickness, anterior chamber depth and axial length. The Metrics App generates OCT images and scan parameters for the anterior chamber such as anterior chamber angle and volume. The four ANTERION Apps are locked/unlocked independently by a license mechanism for each App. The software implementation of these Apps is realized within the AQM and VWM. The following modification has been applied to the device, subject of this 510(k): - · Addition of the Epithelial Thickness Module (separate License in the Cornea App) with maps and parameters of the corneal epithelial and stromal thickness. To function as intended, the ANTERION must be connected to a Medical Image Management and Processing system (MIMPS) with compatible interface. To date, HEYEX 2 / HEYEX PACS is the only available MIMPS with compatible interface.

The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid. SPECTRALIS with Flex Module is intended for imaging of adults and pediatric patients in supine position.

The Heidelberg Engineering SPECTRALIS with Flex Module is based on the predicate SPECTRALIS HRA+OCT consisting of an accessory device mount allowing imaging of patients in supine position. The SPECTRALIS with Flex Module is intended for visualization of the posterior segments of the human eye. The SPECTRALIS with Flex Module is using the identical technologies as the predicate SPECTRALIS tabletop configuration (K223557), i.e. it is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT).

· 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) The Topcon 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic conditions. It is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures. It also includes a reference database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the human retina to a database of known normal subjects. It is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population. All the above functionalities and indications are available in combination with IMAGEnet 6. · Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6 Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid. - · IMAGEnet6 Ophthalmic Data System The IMAGEnetto Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices. It is intended for processing and displaying ophthalmic images and optical coherence tomography data. The IMAGEnet6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects. · Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6 Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2) with system linkage software (herein referred to as "Maestro2") is a non-contact ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography. Maestro2 includes an optical system of OCT, fundus camera (color, IR and Red-free image), and anterior observation camera. Maestro2 is used together with IMAGEnet6 by connecting via System linkage software which is a PC software installed to off the shelf PC connected to Maestro2 is capable of OCT imaging and color fundus photography. For this 510(k) notification, Maestro2 has been modified to allow for OCT "angiographic" imaging (only in conjunction with IMAGEnet6). IMAGEnet6 is a software program installed on a server computer and operated via web browser on a client computer. It is used in acquiring, storing, managing, processing, measuring, displaying of patient information, examination information and image information delivered from TOPCON devices. When combined with Maestro2, IMAGEnet6 plays an essential role as the user interface of the external PC by working together with the linkage software of Maestro2. In this configuration, IMAGEnet6 performs general GUI functions such as providing of the log-in screen, display of the menu icons, display function, measurement, analysis function, image editing functions, storing and management of data of the captured OCT scans and provides the reference database for quantitative comparison. For this 510(k) notification, IMAGEnet6 has been modified to allow for OCT "angiographic" imaging on the Maestro2.

The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for: - · viewing the posterior segment of the eye, including two- and three- dimensional imaging - · cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT) - fundus imaqinq - · fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA) - autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak) - · performing measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various ocular diseases, including: - age-related macular degeneration - macular edema - · diabetic retinopathy - retinal and choroidal vascular diseases - glaucoma The device is indicated for viewing geographic atrophy. The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid. The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases: • a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects • a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laser- scanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image. A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared superluminescent diode and a spectral interferometer are used to create the crosssectional images. The following modifications have been applied to the device subject of this 510(k): - . Addition of scan acquisitions for the SPECTRALIS OCT Angiography Module (OCTA) at 125 kH - Addition of a General-Purpose Graphics Processing Unit (GPGPU)

The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The CIRRUS™ HD-OCT Reference Database is a quantitative tool used for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of healthy subjects. CIRRUS™ HD-OCT AngioPlex angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. The CIRRUS™ HD-OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

The subject device is a computerized instrument that acquires and analyses cross-sectional tomograms of anterior ocular structures (including comea, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. CIRRUS 6000 has a 100kHz scan rate for all structural and angiography scans. The subject device uses the same optical system, and principle of operation as the previously cleared CIRRUS 6000 (K222200) except for the reference database functionality. The subject device contains a newly acquired reference database which was collected on K222200. This study data compares macular thickness, ganglion cell thickness, optic disc and RNFL measurements to a reference range of healthy eyes as guided by the age of the patient and /or optic disc size. Reference database outputs are available on Macular Cube 200x200, and Optic Disc Cube 200x20 scan patterns. All other technical specifications have remained the same as the predicate K222200.

The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. It is intended for in-vivo viewing, digital imaging, and measurement of posterior ocular structures, including the retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc under mydriatic and nonmydriatic conditions. P200TE is indicated for producing high resolution, ultra-widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps. The P200TE includes a Reference Database that enables the results of OCT segmentation analysis to be compared to reference data, including Full retinal thickness, Ganglion Cell Complex thickness, Retina Nerve Fiber Layer thickness and Optic Nerve Head metrics. The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.

The P200TE is a desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and optical coherence tomography. Ultra-widefield images can be captured in less than half a second. The device is intended to be used by ophthalmic and optometry health care professionals. The P200TE delivers images in the following image modes: - . Scanning Laser Ophthalmoscopy - . Reflectance imaging - . Autofluorescence imaging - . Optical Coherence Tomography The P200TE instrument uses red and green laser illumination for reflectance imaging, enabling it to image pathology throughout the layers of the retina, from the sensory retina and nerve fiber layer, through the retinal pigment epithelium (RPE) and down to the choroid. The image can be separated to present the distinct retinal sub-structures associated with the individual imaging wavelengths. The P200TE instrument uses green laser illumination to excite autofluorescence (AF) emission from the naturally occurring lipofuscin in the fundus. The P200TE instrument uses a broadband near-infrared (N-IR) super-luminescent diode (SLD) light source for optical coherence tomography allowing a depth profile of the reflectance of the fundus to be recorded. The P200TE instrument uses N-IR laser illumination for reflectance imaging simultaneously with OCT imaging. Reflectance images are used to track eye position during OCT imaging and are not available to the user. The P200TE images the eye via two ellipsoidal mirrors arranged so that a focal point of one of the mirrors coincides with a focal point of the other mirror; a mirrored scanner is also located at this common focal point. The pupil of the subject's eye is placed at one of the other focal points. A second mirrored scanner is located at the remaining focal point; a laser or SLD reflected off this scanner is relayed onto the second scanner by the first ellipsoidal mirror and from there is reflected through the pupil and into the eve by the second ellipsoidal mirror. The second scanning element is different for OCT and SLO imaging. The energy reflected back from the retina, or emitted by fluorophores, returns through the same path to the detectors; the images are generated from the captured detector data. P200TE OCT images are automatically segmented to identify and annotate retinal layers and structures, enabling practitioners to efficiently assess retinal structures in support of detecting, monitoring and documentation. A Reference Database enables the automatic annotation of OCT segmentation results to provide comparison to a known healthy population. Segmentation outcomes are recorded as annotations and support adjustment as deemed necessary by the clinician. P200TE automatic seqmentation provides comprehensive retinal and optic nerve head information, including: - . Full Retinal Thickness (FRT) - . Ganglion Cell Complex Thickness (GCC) - ONH Analysis - ONH Nerve Fiber Layer Thickness The P200TE refers to the scan head component of the system. together with touchscreen and hand controller. The device is supported by an image server which delivers patient management and image storage, as well as interfacing with the business systems and Electronic Medical Record systems. The images are captured by the scan head under operator control and then automatically saved to the image server that uses a database structure to hold the images and patient information. For subsequent image review, a number of viewing PCs are connected remotely or via a local area network to the image server. The patient records and images are then accessible in a distributed format suited to the physical layout of the eye-care practice. Images can be reviewed through OptosAdvance review software (K162039) either on the image server, or on individual review stations, or other compatible PACS viewers.

The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a noncontact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions. The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures. It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2)is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) with System linkage software (herein referred to as "Maestro2") is a non-contact ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography. Maestro2 includes an optical system of OCT, fundus camera (color. IR and Red-free image), and anterior observation camera. The color fundus camera acquires color images of the posterior segment of the eye under mydriatic or non-mydriatic conditions. Maestro2 is used together with IMAGEnet6 by connecting via System linkage software which is a PC software installed to off the shelf PC connected to Maestro2. The remote operation function is not intended to be used from any further distance (e.g., operation from different rooms or different buildings) other than social distancing recommendations.

RESCAN 700 provides non-contact, high resolution optical coherence tomographic (OCT) and biomicroscopic imaging of the anterior and posterior segment of the eve via an ophthalmic surgical microscope. The RESCAN 700 is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging of posterior ocular structures, including retina, macula, and optic disc, as well as imaging of anterior ocular structures, including the cornea, lens and anterior chamber angle. RESCAN 700 uses the assistance system (CALLISTO eye) that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The assistance system allows the remote control of RESCAN 700.

RESCAN 700 brings Spectral Domain OCT technology to the ZEISS ophthalmic surgical microscopes (e.g. ARTEVO 800). Used in conjunction with the assistance system, CALLISTO eye, OCT images taken intra-operatively are presented on the monitor and may also be seen within the surgeon's oculars using the surgical microscopes integrated data injection system (IDIS). OCT images may be stored for subsequent retrieval using CALLISTO eye's data management system. RESCAN 700 can be controlled via the touch panel of the assistance system or via the foot control panel of an ophthalmic surgical microscope