HALO AP Dx
FDA 510(k) K252762 · Indica Labs, LLC
510(k) numberK252762
Submission
- Device name
- HALO AP Dx
- Applicant
- Indica Labs, LLC
Albuquerque, NM, US - Received
- August 29, 2025
- Decision date
- November 25, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QKQ – Digital Pathology Image Viewing And Management Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.3700
- Specialty
- Pathology
Digital pathology image viewing and management software device 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 and interpret these digital images for the purposes of primary diagnosis.
Other 510(k)s with product code QKQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261380 | Concentriq AP-DxQKQ · Traditional | Proscia, Inc. | 08/05/2026SE |
| K243449 | Infinitt DPSQKQ · Traditional | Infinitt Healthcare Co., Ltd. | 12/09/2025SE |
| K243391 | AISight DxQKQ · Traditional | PathAI, Inc. | 06/26/2025SE |
| K250968 | PathPresenter Clinical ViewerQKQ · Traditional | Pathpresenter Corporation | 06/20/2025SE |
| K250414 | CaloPixQKQ · Traditional | Tribun Health | 05/14/2025SE |
| K242244 | Viewer+QKQ · Traditional | Lumea, Inc. | 03/14/2025SE |
| K241273 | FullFocusQKQ · Traditional | Paige.Ai, Inc. | 01/09/2025SE |
| K240303 | MetaLite DX Digital Pathology SoftwareQKQ · Traditional | Jellox Biotech, Inc. | 10/28/2024SE |
| K233126 | aetherSlideQKQ · Traditional | Aetherai Co., Ltd. | 05/30/2024SE |
| K212361 | NovoQKQ · Traditional | PathAI, Inc. | 08/11/2022SE |
More from PathAI, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232833 | HALO AP DxPSY · Traditional | 05/07/2024SE |
Questions and answers
When was HALO AP Dx cleared by the FDA?
HALO AP Dx (K252762) received a 510(k) decision of Substantially Equivalent on November 25, 2025, 88 days after the submission was received.
What is the product code of K252762?
The FDA product code is QKQ – Digital Pathology Image Viewing And Management Software, a Class II (moderate risk) device regulated under 21 CFR 864.3700.