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AISight Dx is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of these slides for primary diagnosis. AISight Dx is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. AISight DX is intended to be used with interoperable displays, scanners and file formats, and web browsers that have been 510(k) cleared for use with the AISight Dx or 510(k)-cleared displays, 510(k)-cleared scanners and file formats, and web browsers that have been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying interoperable devices.

AISight Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation, and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner or Leica Aperio GT 450 DX scanner (Table 1). It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.

For In Vitro Diagnostic Use Only CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue. CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and the validity of the interpretation of images using CaloPix. CaloPix is intended to be used with the interoperable components specified in the below Table: | Scanner Hardware | Scanner Output File Format | Interoperable Displays | |---|---|---| | Leica Aperio GT 450 DX scanner | SVS | Dell U3223QE | | Hamamatsu NanoZoomer S360MD Slide scanner | NDPI | JVC Kenwood JD-C240BN01A |

CaloPix, version 6.1.0 IVDUS, is a web-based software-only device that is intended to aid pathology professionals in viewing, interpreting and managing digital Whole Slide Images (WSI) of glass slides obtained from the Hamamatsu NanoZoomer S360MD slide scanner (NDPI file format) and viewed on the JVC Kenwood JD-C240BN01A display, as well as those obtained from the Leica Aperio GT 450 DX scanner (SVS file format) and viewed on the Dell U3223QE display. CaloPix does not include any automated Image Analysis Applications that would constitute computer aided detection or diagnosis. CaloPix is for viewing digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. As a whole, CaloPix is a pathology Image Management System (IMS) which brings case-centric digital pathology image management, collaboration, and image processing. CaloPix consists of: - Integration with Laboratory Information Systems (LIS): Allows to obtain automatically from the LIS patient data associated with the cases, scanned whole slide images and other related medical images to be analyzed. The data stored in the database is automatically updated according to the interface protocol with the LIS. - DataBase: After ingestion, scanned WSI can be organized in the CaloPix database consisting of folders (cases) containing patient identification data and examination results from a LIS. Ingestion of the slides is performed through an integrated module that allows their automatic indexation based on patient data retrieved from the LIS. After their ingestion, image files are stored in a CaloPix-specific file storage environment, that can be on premises or in the cloud. - The CaloPix viewer component to process scanned whole slide images, that includes functions for panning, zooming, screen capture, annotations, distance and surface measurement, and image registration. This viewer relies on image servers (IMGSRV) which extract image tiles from the whole slide image file and send these tiles to the CaloPix viewer for smooth and fast viewing.

For In Vitro Diagnostic Use Viewer+ is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis. Viewer+ is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. Viewer+ is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner and BARCO MDPC-8127 display.

Viewer+, version 1.0.1, is a web-based software device that facilitates the viewing and navigating of digitized pathology images of slides prepared from FFPE-tissue specimens acquired from Hamamatsu NanoZoomer S360MD Slide scanner and viewed on BARCO MDPC-8127 display. Viewer+ renders these digitized pathology images for review, management, and navigation for pathology primary diagnosis. Viewer+ is operated as follows: - 1. Image acquisition is performed using the NanoZoomer S360MD Slide scanner according to its Instructions for Use. The operator performs quality control of the digital slides per the instructions of the NanoZoomer and lab specifications to determine if re-scans are necessary. - 2. Once image acquisition is complete and the image becomes available in the scanner's database file system, a separate medical image communications software (not part of the device) automatically uploads the image and its corresponding metadata to persistent cloud storage. Image and data integrity checks are performed during the upload to ensure data accuracy. - 3. The subject device enables the reading pathologist to open a patient case, view the images, and perform actions such as zooming, panning, measuring distances and areas, and annotating images as needed. After reviewing all images for a case, the pathologist will render a diagnosis.

For In Vitro Diagnostic Use FullFocus is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis. FullFocus is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. FullFocus is intended to be used with the interoperable components specified in the below Table. Table: Interoperable components of FullFocus | Scanner Hardware | Scanner Output file format | Interoperable Displays | |-------------------------------------------|----------------------------|------------------------------------------| | Leica Aperio GT 450 DX scanner | DICOM, SVS | Dell UP3017<br>Dell U3023E | | Hamamatsu NanoZoomer S360MD Slide Scanner | NDPI | Dell U3223QE<br>JVC-Kenwood JD-C240BN01A |

FullFocus, version 2.29, is a web-based software-only device that facilitates the viewing and navigating of digitized pathology images of slides prepared from FFPE-tissue specimens acquired from FDA cleared digital pathology scanners on FDA cleared displays. FullFocus renders these digitized pathology images for review, management and navigation for pathology primary diagnosis. Image acquisition is performed using the intended scanner (s), with the operator conducting quality control on the digital WSI images according to the scanner's instructions for use and lab specifications to determine if re-scans are needed. Please see the Intended Use section and below tables for specifics on scanners and respective displays for clinical use. Once a whole slide image is acquired using the intended scanner and becomes available in the scanner's database file system, a separate medical image communications software (not part of the device), automatically uploads the image and corresponding metadata to persistent cloud storage. Integrity checks are performed during the upload to ensure data accuracy. The subject device enables the reading pathologist to open a patient case, view the images, and perform actions such as zooming, panning, measuring distances and annotating images as needed. After reviewing all images for a case, the pathologist will render a diagnosis. FullFocus operates with and is validated for use with the FDA cleared components specified in the tables below: | Scanner Hardware | Scanner Output file format | Interoperable Displays | |-------------------------------------------|----------------------------|------------------------------------------| | Leica Aperio GT 450 DX scanner | DICOM, SVS | Dell UP3017<br>Dell U3023E | | Hamamatsu NanoZoomer S360MD Slide Scanner | NDPI | Dell U3223QE<br>JVC-Kenwood JD-C240BN01A | Table 1: Interoperable Components Intended for Use with FullFocus FullFocus version 2.29 was not validated for the use with images generated with Philips Ultra Fast Scanner. Table 2: Computer Environment/System Requirements for during the use of FullFocus | Environment | Component | Minimum Requirements | |-------------|------------------|-----------------------------------------------------------------------------------------| | Hardware | Processor | 1 CPU, 2 cores, 1.6GHz | | | Memory | 4 GB RAM | | | Network | Bandwidth of 10Mbps | | Software | Operating System | • Windows<br>• macOS | | | Browser | • Google Chrome (129.0.6668.90 or higher)<br>• Microsoft Edge (129.0.2792.79 or higher) |

For In Vitro Diagnostic Use MetaLite DX Digital Pathology Software is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides. MetaLite DX Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. MetaLite DX Digital Pathology Software is intended for use with Philips Ultra Fast Scanner and the Barco MDPC-8127 display.

MetaLite DX Digital Pathology Software, Model MLDXUS, version 1.2.1 is software designed for viewing digital pathology images of glass slides from the Philips IntelliSite Pathology Solution Ultra-Fast Scanner (PIPS-UFS), version 1.8.4 on Barco MDPC-8127 display. MetaLite DX Digital Pathology Software is operated as follows: Before scanning the slide on the PIPS-UFS, the technician performs quality control on the tissue of interest. The images captured by the PIPS-UFS are compressed using Philips' proprietary iSyntax format and are transmitted to the Philips Image Management System (IMS). (1) After the Whole Slide Images (WSIs) are successfully, acquired by using PIPS-UFS, the WSIs are stored in the Local file system. A qualified pathologist will upload compatible iSyntax format digital pathology images, and the software will load them to the "Main Viewer" area of the graphical interface for the pathologist to view. (2) Once properly loaded, the pathologist will use the inherent features of the device (including tools that allow for adjusting the position and viewing angle of the image, measuring lengths between two coordinates, and adding annotations to specific regional areas). (3) After viewing all images for a patient (case), the pathologist will make a diagnosis. The diagnosis will be documented in another system, e.g., a Laboratory Information System (LIS). The software has various features such as zoom-in and zoom-out functions, scale display, thumbnail view, measurement function, annotation function, and panning function to help pathologists interpret, diagnose and manage digital whole slide images. The MetaLite DX Digital Pathology Software is validated for use with the components specified the tables below.

For In Vitro Diagnostic Use aetherSlide is a software-only device intended for viewing and managing digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis. aetherSlide is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. aetherSlide is intended for use with the Philips Ultra Fast Scanner (UFS) and the Philips PS27QHDCR monitor.

aetherSlide, version 101692 is a web-based, software only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue obtained from Philips Ultra Fast Scanner (UFS). It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.

Novo is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of these slides for primary diagnosis. Novo is not intended for use with frozen sections, cytology, or non- FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. Novo is intended for use with the Philips Ultra Fast Scanner and the Barco PP27QHD or Philips PS27QHDCR display.

The PathAI Novo device is a web-based software-only device that is intended to aid pathology professionals in the viewing, interpretation, and management of digital whole slide images (WSIs) of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue using the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS). The proposed device is typically operated as follows: - 1. A user prepares and scans slides and reviews the slide quality in accordance with the PIPS UFS IFU and standard lab procedures. The Novo device workflow is initiated when a user uploads WSIs from the local file system to the cloud storage using Novo. - 2. After uploading WSIs to cloud storage using Novo, a user builds a patient accession using the patient's medical record number (MRN), date of birth (DOB) and accession ID to support linkage of one or more slides from a single procedure using patient identifiers in Novo. - 3. A pathologist uses the slide viewer to perform their primary diagnosis workflow including zooming and panning images. After viewing all images belonging to a particular accession, the pathologist will make a diagnosis.

Dynamyx Digital Pathology Software is intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software. The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips' Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips' Ultra Fast Scanner and Philips PP27QHD monitor.

Dynamyx Digital Pathology Software is a client-server software device used for importing, displaying, navigating, and annotating whole slide images obtained from the Leica Aperio AT2 DX scanner or the Philips Ultra Fast Scanner. Whole slide images are created by scanning glass microscope slides using a digital slide scanner which are then imported into the Dynamyx Digital Archive server. Dynamyx uses the image decoding libraries licensed by Leica and Philips for the native images. Dynamyx then uses lossless compression to send the images to the Dynamyx viewer. Note that Dynamyx has two different applications for two different inputs as specified below. 1. The Dynamyx Web Application running in the Chrome browser can only display WSI from the Philips Ultra Fast Scanner. 2. The Dynamyx Installed Client Application can display WSI from both the Leica AT2 DX Scanner and the Philips Ultra Fast Scanner. Whole slide image files are viewed in the Dynamyx image viewer window by histologists and by pathologists who can also navigate (pan and zoom) and annotate the images. Dynamyx incorporates typical histology/pathology workflow and is operated as follows: - 1. Dynamyx receives whole slide images from the scanner as specified above and extracts a copy of the images' metadata. The unaltered images are then sent to the external image storage (Digital Archive). A copy of the image metadata (e.g. the pixel size) is stored in the subject device's database to increase the operational performance (e.g. response times) of Dynamyx. - 2. Depending upon a laboratory's workflow, whole slide images may be reviewed first by histologists to confirm image quality and initiate any slide rescans as necessary prior to being viewed by pathologists. The digital slide review OC status determined by the histologist indicates which slides have been reviewed and approved. The OC status is available to the reading pathologist. - 3. The reading pathologist selects a patient case from a selected worklist within Dynamyx whereby the case images are retrieved from the digital archive. - 4. The reading pathologist uses Dynamyx to view, navigate, annotate, and interpret the digital images. The pathologist can perform the following actions to displayed image: - a. Zoom and pan the image at will; - b. Adjust the apparent image observed magnification level; - c. Measure distances and areas; - d. Annotate images and cases; - 5. The above steps are repeated as required. After viewing all images, the pathologist will make a diagnosis which is documented in a laboratory information system.

FullFocus™ is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of pathology slides for primary diagnosis. FullFocus is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. FullFocus is intended for use with Philips Ultra Fast Scanner and monitor displays validated with verified test methods to meet required performance characteristics.

FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus reproduces the whole slide images and is an aid to the pathologist to review. interpret and manage digital images of pathology slides for primary diagnosis.

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.

Sectra Digital Pathology Module is a software-only device running under the Microsoft Windows operating system for displaying and manipulating digital pathology images (scanned slides) obtained from the Aperio AT2 DX scanner. Sectra Digital Pathology Module may only be used in combination with Sectra PACS which consists of Sectra Workstation (K081469) and Sectra Core (identified as a Class I exempt by the FDA in 2000). The Sectra Pathology Import Server (SPIS) is used for importing digital pathology images (scanned slides) from the scanner. These images are viewed and manipulated by end users in the Pathology Image Window which is displayed on the Sectra Workstation IDS7 (using the Dell MR2416 monitor).