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iCare ALTIUS CW is a Medical Device Software indicated for the review, processing and analysis of ophthalmic medical images, for the review of video, clinical and diagnostic data, measurements and reports, generated by ophthalmic medical devices or documentation system through computerized networks, to support trained healthcare professionals in the diagnosis and monitoring of several eye pathologies.

iCare ALTIUS CW is a cloud-based software application with a web-based interface able to: - review medical ophthalmic images, including videos, - digitally process images, - review diagnostic data, clinical information and reports, from ophthalmic diagnostic instruments. CW does not perform automated image analysis but provides advanced imaging manipulation tools. CW allows to review and process diagnostic data and multiple images with different formats (e.g. PDFS, JPEG, ...) and provides the following features: - image manipulation filters such as zooming, changing brightness and contrast and gamma, RGB filtering, - side-by-side image comparison (detached or synchronized mode) with different layouts, - advanced imaging tools, such as flicker between different pictures and mosaics of several images, - review and print reports generated by ophthalmic devices. CW integrates with PACS software systems, which provide the medical images and reports, to be analysed by the CW. The patient data and medical images exchange between CW and PACS is done through computerized networks using secured network communication. The web-based interface of CW is designed to be used through a desktop PC or a laptop using keyboard and mouse (further details in the technical requirements section). The User Interface is available in the languages required by the applicable regulatory requirement of the country where the device is placed on the market.

The IMAGEnet6 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.

IMAGEnet6 Ophthalmic Data System is a Web application that allows management of patient information, exam information and image information. It is installed on a server PC and operated via a web browser of a client PC. When combined with 3D OCT-1 (type: Maestro2), IMAGEnet6 provides GUI for remote operation function. This function is an optional function which enables users to use some of the image capture function by operating the PC or tablet PC connected to the external PC of 3D OCT-1 (Type:Maestro2) device via ethernet cable. 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.

CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of ARTEVO 750/850 and RESCAN 700, and display images of the anterior and posterior segment of the eye. CALLISTO eye Software is indicated as graphical guidance aid to insert, align, position, and register an intraocular lens (IOL) including toric IOLs, limbal relaxing incisions, and capsulorhexis during anterior segment surgical procedures.

CALLISTO eye software version 5.0 is a new release sporting a new user interface but carries the clinical feature set of software version 3.7.2: it supports the digital visualization technology and connectivity of ARTEVO 750 / ARTEVO 850 and provides connectivity to the QUATERA700. CALLISTO eye enables the video visualization of the anterior segments of the eye and allows the connection and remote control of a surgical microscope with and without OCT Camera. It is designed for high patient throughput and can be used for teaching purposes. CALLISTO eye is an assistance system that processes real-time video images that can be displayed on the CALLISTO eye Panel PC for viewing by the surgeon and the surgical staff in the operating room. The same video images can be viewed by the surgeon through the eyepiece of the connected surgical microscope. CALLISTO eye provides Assistant Functions displaying treatment templates as screen overlays and Cockpits displaying patient and device information as screen overlays. Both functions assist the surgeon during procedures such as limbal relaxing incisions, capsulorhexis, and alignment of toric intraocular lenses (TIOL). All treatment templates are based on preoperative clinical data of a particular patient and shall be defined by the surgeon prior surgery. These templates can be displayed on the CALLISTO eye Panel PC, through the eyepiece of the surgical microscope equipped with a data injection system (IDIS (WITH VERSION 5.0 RELABELED AS ADVISION)) of the ARTEVO 750 or on a 3D monitor connected to the ARTEVO 850. While using "ASSISTANCE markerless" configuration, CALLISTO eye can utilize the preoperative diagnostic data from the Zeiss IOLMaster and may provide the reference and target axis as required to align a toric intraocular lens without the otherwise required ink marks. Transmission of the diagnostic data from the IOLMaster to CALLISTO eye takes place via USB stick or via a data network connected to a DICOM compatible MIMPS server such as FORUM. The DICOM functionality allows the indirect communication with other DICOM compatible diagnostic devices and patient information systems to exchange patient data (e.g. medical devices work lists).

Harmony is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management of patient data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.

Harmony is a modification to the existing Harmony cleared in K182376. The differences between the new version and the currently cleared version are modifications to the graphical user interface consisting of PixelSmart Technology, Internationalization support, Analytical thickness grids, Hanging protocols, and Automatic image smoothing while zooming in. Harmony is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye, as well as for management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks. Harmony is used together with a number of computerized digital imaging devices, including: - Optical Coherence Tomography devices . - Mydriatic retinal cameras . - Non-mydriatic retinal cameras . - Biomicroscopes (slit lamps) In addition, Harmony collects and manages patient demographics, image data, and clinical reports from a range of medical devices, including: - Scanning Laser Ophthalmoscope images and videos . - Non Radiometric Ultrasound devices ● - Video image sources ● - TWAIN compliant imaging sources ● - Compliant data sources placed in network accessible folders and directories - . Images of known format from digital cameras and scanners - . Printer files of known format form computerized diagnostic devices - Electronic information complying to accepted DICOM formats - Other devices connected in proprietary formats ● There are 5 notable device modifications subject of this submission: PixelSmart Technology, International support, Analytical thickness grids, Hanging protocols, and Automatic image smoothing while zooming in, along with some minor modifications. PixelSmart is an optional post-processing image enhancement algorithm performing a moving average across OCT B-scans, reducing speckle noise and improving contrast by applying smoothing. International support adds the possibility to use the Harmony user interface and online user manual in Spanish, in addition to the standard English software. Analytical thickness grids offer the same functionality as the existing, cleared thickness grids in Topcon's IMAGEnet 6, now also in Harmony. The grids show sectorial average thickness values as derived from OCT segmentation data. Hanging protocols allows a customizable image display arrangement in the Harmony user interface, resembling the arrangement of physical images on a light box. Automatic image smoothing while zooming in is an optional display feature that will cause OCT B-scan images on higher zoom levels to look less pixelated.

CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of OPMI Lumera family and RESCAN 700, and display images of the anterior and posterior segment of the eye. CALLISTO eye Software is indicated as graphical guidance aid to insert, align, position, and register an intraocular lens (IOL) including toric IOLs, limbal relaxing incisions, and capsulorhexis during anterior segment surgical procedures.

CALLISTO eye software operates as an adjunct to the ZEISS's family of ophthalmic surgical microscopes to process surgery videos and OCT data (B-Scan images). Specifically, the subject device has the functionality to be connected to an OCT camera (such as in RESCAN 700 (K180229)), a phaco machine (such as in QUATERA 700 (K212241), as well as MIMPS (such as FORUM (K213527). CALLISTO eye Software must be installed on a computer with a touchscreen; this Panel PC (ORPC) is offered as an accessory. The current model of the ORPC is the CALLISTO eye Panel PC Model II. OPRC function and configuration has been modified since the last CALLISTO eye 510(k) by upgrading electronics components to accommodate lifecycle management needs. CALLISTO eye 3.7.2 has the same functionalities as CALLISTO eye 3.6 (K180858). These functionalities include patient data management and transmission via DICOM protocol, interfaces to ZEISS's ophthalmic microscopes with/without OCT camera (RESCAN 700) and assists with overlay function for markerless marking to support IOL alignment. Additional functionalities unique to CALLISTO eye 3.7.2 are inclusion of changes occurring from software version 3.6 to 3.7.1 and additional support of language packages, bug fixes, cybersecurity enhancements and interoperability abilities with a phaco system (OUATERA 700). The subject device, CALLISTO eye 3.7.2, provides connectivity to the following surgical microscopes from ZEISS: - . OPMI LUMERA 700 with Integrated Data Injection System (IDIS) - OPMI LUMERA T with External Data Injection System (EDIS) ● - OPMI LUMERA I with External Data Injection System (EDIS) . - OPMI LUMERA 700 with OCT camera (RESCAN700) - ARTEVO 800 with 3D monitor cart (3DIS) . - ARTEVO 800 with OCT camera (RESCAN700) . The software can acquire photo and videos from all surgical microscope listed above and can remote control these microscopes apart from the OPMI LUMERA T and I. All OPMI LUMERA family surgical microscopes have been covered by the predicate device CALLISTO eye 3.6 (K180858). With the subject device the range of supported surgical microscopes was extended to the ARTEVO 800 with and without RESCAN700 as principal successor of the OPMI LUMERA 700. The intended use and indications for use of OPMI LUMERA and ARTEVO 800 are identical and the microscopes can be applied for the same surgical procedure. CALLISTO eye allows the connection and remote control of a surgical microscope with or without OCT Camera and thus operates as an adjunct to the family of ZEISS surgical microscopes. Functionalities such as light intensity, camera parameters, start/stop recording, zoom, focus, diaphragm, start/stop OCT scanning, etc. of the surgical microscope, including the configuration of the foot control panel and handgrips, can be accessed and managed by the user in CALLISTO eye. CALLISTO eye Software is an assistance, information system to support ophthalmic surgical procedures. It provides an interface to other devices to facilitate the: - Display and recording of video data provided by ZEISS surgical microscopes (OPMI) . - Display of assistance functions (graphical guidance templates) and device information (cockpits) to aid the surgeon in the implantation of intra ocular lenses; e.g., used for the alignment for toric intraocular lenses. - . Display and recording of OCT image data provided by ZEISS RESCAN 700 - Display and exchange data with the ZEISS OUATERA 700 phacoemulsification and vitrectorny system . - . Retrieval and storage of patient data from and to the FORUM MIMPS system - . Configuration of ZEISS surgical microscopes, including the assignment of functions to OPMI handgrips and foot control panel

The Altris IMS is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, and measure data from ophthalmic diagnostic instruments, including patient data, diagnostic data, clinical images and information, reports, and measurement of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.

Altris IMS is a cloud-based software program to assist healthcare professionals, specifically Eye Care Practitioners (ECPs) with OCT interpretation. Altris IMS utilizes commonly available internet browsers to locally manage and review data which is uploaded to an Amazon AWS cloud-based server. Its intended use is to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including patient data, diagnostic data, clinical images and information, reports, and measurement of DICOM-compliant images. The platform allows the user to manually annotate areas of interest in the images, calculate the layer thickness and volume from annotated images and present the progression of the measurements. Altris IMS also provides a tool for linear distance measuring of ocular anatomy and ocular lesion distances. The platform supports DICOM format files. Altris IMS is focused on the center sector of the retina. Altris IMS does not perform optic nerve analysis. Altris IMS has tools for manual area of interest image segmentation and labeling/annotation for healthcare professionals to use and review for their own diagnosis. The Subject device neither performs any diagnosis, nor provides treatment recommendations. It is solely intended to be used as a support tool by trained healthcare professionals. The software does not use artificial intelligence or machine learning algorithms. The Subject device is a client-server model. It utilizes a local user/client internet browser-based (frontend) interface used to upload, manage, annotate, and review imaging data. Data is stored and processed on a remote web-based server (backend).

Ophthalmology The EXCELSIOR Software is intended for use in importing, processing, measurement, and analysis of ophthalmic clinical images as well as in management of clinical data, through a computerized network for use in analysis of images and data obtained in clinical trials. Radiology Excelsior is a software solution intended to be used for viewing, manipulation, annotation, and ysis, and comparison of medical images from multiple imaging modalities and/or multiple time points. The application supports images, functional data such as PET as well as anatomical datasets, such as CT or MR. Excelsior is a software only medical device to be deployed through a cloud-based computerized network via web applications and customized user interfaces for use in the analysis of images and data obtained in clinical trials. Excelsior enables visualization of information that would otherwise have to be visually compared disjointedly. Excelsior provides and workflow automation tools to help the user assess and document the extent of a disease and/or the response to therapy in accordance with user selected standards and assess changes in imaging findings over multiple time-points. Excelsior supports the interpretation and evaluations and follow-up documentation of findings for radiologic oncology imaging and data obtained in clinical trials. The product is intended to be used as a workflow automation tool by trained medical professionals. It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings. Note: The medical professional retains the ultimate responsibility for making the pertinent observations based on their standard practices and established practices related to clinical trial outcomes. Excelsior is a complement to these standard procedures. Excelsior is not to be used in mammography.

The EXCELSIOR software is a cloud-based software that provides a central reading platform integrating remote data collection, quantitative analysis and measurement, storage, and management of ophthalmic and radiological data from DICOM images for clinical trials. The software does not use artificial intelligence or machine learning algorithms.

FORUM is a software system intended for use in management, processing of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications (including but not limited to Retina Workplace, Glaucoma Workplace). FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.

FORUM and its accessories are a computer software system designed for management, processing, and display of patient diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications. FORUM receives data via DICOM protocol from a variety of ophthalmic diagnostic instruments (such as CIRRUS, CLARUS, and 3rd Party systems), allows central data storage and remote access to patient data. This version of FORUM allows the user to access their data in the cloud via ZEISS developed non-medical device accessories. FORUM is an ophthalmic data management solution. FORUM provides basic viewing functionalities and is able to connect all DICOM compliant instruments. This version of FORUM provides additional device functions such as review and annotation functionality of fundus images/movies, display of OCT image stacks, bidirectional data exchange between FORUM Workplaces, customization of document viewing abilities, user interface improvements, and user management updates. This version of FORUM has additional non-medical device functions that are performed by non-medical device accessories, such as documentation storage, export of data in various formats, export to the cloud, improved IT integration capability into the existing IT network, image sorting, EMR log in improvements, numerous backend improvements with the purpose of streamlining clinical workflow.

The RetinAl Discovery is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, clinical images and information, reports and measurements of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.

The RetinAl Discovery consists of a platform which displays and analyzes images of the eye (e.g. OCT scans and fundus images) along with associated measurements (e.g. layer thickness) generated by the user through Discovery. The platform allows the user to manually segment layers and volumes in the images, it calculates the layer thickness and volume from annotated images and presents the progression of the measurement in graphs. Discovery provides a tool for measuring ocular anatomy and ocular lesion distances. The multiple views in Discovery and the measurements allow the user to assess the eye anatomy and, ultimately, assist the user in making decisions on diagnosis and monitoring of disease progression.

Harmony Referral System (Harmony RS) is a comprehensive software platform intended for use in importing, processing, viewing, measurement and storage of clinical images and videos as well as in management and communication of patient data, diagnostic and clinical information and reports from ophthalmic diagnostic instruments through either direct connection with the instruments or through computerized networks. The system neither performs any interpretations nor provides treatment recommendations.

Harmony Referral System is an internet-browser-based software platform that allows users to access examination data of a patient from different sources. Harmony Referral System may be used together with a number of computerized digital imaging devices and third party software. In addition. Harmony Referral System software collects and manages patient demographics, image data, and clinical reports from a range of approved medical devices. Harmony Referral System enables a real-time review of diagnostic patient information at a PC workstation. The software uses SSL encryption in network communication and secure network infrastructure with firewalls and additionally also VPN and IP-based access restrictions to ensure secure networking environment. The Harmony Referral System does not perform automated image analysis but provides measurements based on pixels of an image, which were marked by the user manually on the screen including cup-disk ratio and line and area measurements.