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HALO AP Dx is a software only device intended as an aid to the pathologist to review, interpret and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. HALO AP Dx 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. HALO AP Dx is intended for use with the interoperable components specified in the Table below.

HALO AP Dx, version 2.4 (abbreviated as v2.4), is a browser-based software-only device intended to aid pathology professionals in viewing, manipulating, management, and interpretation of digital pathology whole slide images (WSI) of glass slides obtained from the Hamamatsu Photonics K.K. NanoZoomer S360MD scanner or the Leica Biosystems Imaging, Inc. Aperio GT 450 DX.

HALO AP Dx is typically operated as follows:

1. Image acquisition is performed using the predicate device. The operator performs quality control of the digital slides per the instructions of the predicate device and lab specifications to determine if re-scans are necessary.

2. Once image acquisition is complete, according to its Instructions for Use, the unaltered image is saved in an external image storage location. HALO AP Dx ingests the image, and a copy of image metadata is stored in the subject device's database to improve viewing response times.

3. Depending upon a laboratory's workflow, the scanned images may first be reviewed by histotechnicians to confirm image quality and initiate any re-scans. After review, the histotechnician may modify the case status and make it available to the pathologist.

4. The reading pathologist selects a patient case from a selected worklist within HALO AP Dx whereby the subject device fetches the associated images from external image storage.

5. The reading pathologist uses the subject device to view the images and can perform the following actions, as needed:
   a. Zoom and pan the image.
   b. Measure distances and areas in the image.
   c. Annotate images.
   d. View multiple images side by side in a synchronized fashion.

6. The above steps are repeated as necessary.

After viewing all images belonging to a particular case (patient), the pathologist will make a diagnosis which is documented in another system, such as a Laboratory Information System.

HALO AP Dx operates and is validated for use with the FDA cleared components listed in the intended use statement table above.

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