Halo AP Dx Whole Slide Imaging System
by Indica Labs, Inc. United States EUDAMED510(k)
510(k) K232833
Product code PSY
Overview
The Halo AP Dx is a Whole Slide Imaging System, designed for digital pathology. It converts glass-mounted tissue slides into high-resolution digital images, enabling remote analysis, second-opinion consultations, and integration with digital pathology workflows. This system supports automated scanning and image processing to enhance diagnostic accuracy and efficiency in pathology settings.
The device is supplied as a reusable system intended for use in pathology laboratories. It operates in a non-sterile environment and is not classified as single-use. The system is MRI-safe and includes multiple model variants, as indicated by the registration numbers. Authorised under FDA 510K and IVDR compliance, it adheres to regulatory standards for digital pathology imaging systems, ensuring reliability and traceability in diagnostic workflows.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK232833 | Date7 May 2024 | StatusActive |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- Full name
- HALO AP Dx
- 510(k) Number
- FDA Product Code
- PSY
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.3700
- Advisory Committee
- Pathology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Indica Labs
Questions
What types of pathology workflows can the Halo AP Dx support, and how does it improve diagnostic processes?
The Halo AP Dx is designed for digital pathology workflows, enabling remote analysis and second-opinion consultations by converting glass-mounted tissue slides into high-resolution digital images. It supports automated scanning and image processing, which enhances diagnostic accuracy and efficiency in pathology laboratories by streamlining workflows and reducing reliance on physical slide handling.
Is the Halo AP Dx intended for single-use or reusable applications, and how does this affect its maintenance?
The Halo AP Dx is explicitly supplied as a reusable system and is not classified for single-use. Since it operates in a non-sterile environment, maintenance involves routine cleaning and calibration to ensure consistent performance over repeated use in pathology settings. The manufacturer’s guidelines should be followed for proper upkeep.
What model variants or configurations are available for the Halo AP Dx, and how do they differ?
The Halo AP Dx includes multiple model variants, as indicated by its registration numbers (e.g., 3017125738, 3000126629, etc.). While the exact specifications of each variant are not detailed here, these likely correspond to different configurations or capacities (e.g., scanning speed, resolution, or slide capacity). Buyers should consult Indica Labs’ documentation or support for precise differences between models.
How does the Halo AP Dx ensure compliance with regulatory standards, and what certifications does it hold?
The Halo AP Dx is authorized under FDA 510K and IVDR compliance, meeting regulatory standards for digital pathology imaging systems. Its classification as a Class II device (per OpenFDA) ensures it undergoes rigorous review for safety and effectiveness. The system also adheres to traceability requirements, supporting reliable diagnostic workflows in pathology.
Can the Halo AP Dx be used in environments with MRI equipment, and what safety considerations apply?
Yes, the Halo AP Dx is MRI-safe, meaning it can be used in proximity to MRI machines without interference or safety risks. However, standard MRI safety protocols (e.g., avoiding metallic contamination in scan rooms) should still be followed, as the device itself is not a medical implant or active MRI component. Always verify compatibility with your facility’s MRI protocols.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K232833
- EUDAMED