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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).

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 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 laserscanning 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 cross-sectional images. The following changes have been applied to the device subject of this 510(k): - Widefield Reflectance mode for artifacts suppression - Regression analysis in Glaucoma Module Premium Edition - Thunderbolt 3 interface - Thunderbolt cable fan - Process separation of acquisition software module - Windows 11 Support

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.1.2.4) (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. Placed within the stand are a stepper motor with additional mechanical parts and a controller board, 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 eye. The ANTERION device provides four separate software applications (Apps) to acquire various imaging and measurements of the anterior segment of the eye: (1) the Imaging App (cleared under K211817), (2) the Cornea App, (3) the Cataract App and (4) the Metrics App. The Cornea App provides tomographic data and measurements paraments 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 the 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. This submission is to seek clearance for the Metrics App, Cataract App and Cornea App. 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 ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization of the anterior segment.

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/Basis) 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 (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 PC software additionally stores, receives, and displays the acquired data. The ANTERION hardware is separated in three parts: the Basis (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 Basis and controlled via a ioystick. Placed within the stand are a stepper motor with additional mechanical parts and a controller board, 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 Basis 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, while the IR camera allows for en-face imaging of a patient's eye. The Imaging App, the subject of this submission, is the foundation of the ANTERION platform, and focuses on the high-resolution visualization of the entire anterior segment, from the anterior surface of the cornea to the posterior surface of the lens. The Imaging App delivers swept-source OCT images that allow visualization of anterior segment pathologies and evidence of surgical interventions, e.g. keratoplasty, LASIK, implanted IOLs, and phakic lenses.

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 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 laserscanning 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 cross-sectional images. Because of discontinuation of device components, the following changes have been applied to the device: - . Replacement of the OCT line camera in the spectrometer with an equivalent camera from the same manufacturer, and comparable specifications; - . Update of the digital device interface from Thunderbolt to Thunderbolt 2; - With the update of the TDI, the device complies with electromagnetic compatibility standard IEC 60601-1-2 Edition 4.0.

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 superluminescent diode and a spectral interferometer are used to create the cross-sectional images. The purpose of this premarket notification [510(k)] is to add the High Magnification Module (HMM) as an optional, exchangeable accessory objective lens to the SPECTRALIS HRA+OCT. The HMM is offering an 8° field of view (FOV) and allows for cSLO imaging only. It offers a magnified view of parts of the retina with improved resolution. Compared to the standard objective with 30° FOV, it has an approximately 4 times increased digital resolution, with optical resolution approximately 25% improved compared to the standard objective. With the new HMM objective, the digital resolution for a FOV of 8° is 1536x1536 pixels for High Resolution imaging, and 768x768 pixels for High Speed imaging. The functionality for averaging images with the proprietary automatic real-time (ART) eye tracking is still maintained. cSLO imaging with the HMM is only intended for qualitative use. - No quantitative automatic measurements are performed on HMM images. - - No classifications against reference data are performed on HMM images - Besides the addition of the optional High Magnification Module, the SPECTRALIS device is unchanged.