Search Results

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.

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.