# K252762: HALO AP Dx

- Pathway: 510(k) (Traditional)
- Applicant: Indica Labs, LLC
- Decided: Nov 25, 2025 after 88 days
- Product code: QKQ (Digital Pathology Image Viewing And Management Software)
- Device class: 2
- Regulation: 21 CFR 864.3700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN160056 (2017). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233027: NanoZoomer S360MD Slide scanner system, Hamamatsu Photonics K.K. (2023) Summary page 5.
- K232202: Aperio GT 450 DX, Leica Biosystems Imaging, Inc. (2024) Summary page 5.

## Indications for 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. 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.

Source page: https://510kreport.com/device/K252762
Methodology: https://510kreport.com/methodology