HALO AP Dx
Indica Labs, LLCHALO AP Dx is a software-only device that helps pathologists review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded tissue. It supports quality control and improves workflow by providing image manipulation tools such as zoom, pan, measurement, and annotation within browser-based interfaces, facilitating primary diagnosis.
Intended Use
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.
Technology
HALO AP Dx is a browser-based software device that ingests unaltered whole slide images from FDA-cleared digital slide scanners (Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX), stores metadata to improve response time, and provides tools for image zooming, panning, measurement, annotation, and side-by-side synchronized viewing.
Performance
Performance testing included pixel-level image reproduction comparisons between HALO AP Dx and predicate image review/manipulation software across various browsers and displays, confirming pixel equivalence. Turnaround times for image loading, panning, and zooming meet defined criteria. Measurement accuracy was validated using known size test images. Human factors testing confirmed usability.
Predicate Devices
No predicate devices specified
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