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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) |

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.