SlideQC BF for HALO AP® is an automated, AI-powered application for H&E-stained digitized slides that detects the most common artifacts including air bubbles, dust/debris, folds, out-of-focus areas, and pen marks generated during the process of slide preparation and whole slide imaging. It is seamlessly integrated into the HALO AP diagnostic digital pathology platform. For more information, visit the SlideQC BF product page.
Regulatory Compliance
SlideQC BF is intended to be used as a quality control tool for whole slide images and is not regulated as a medical device in the EU/UK. SlideQC BF is for Research Use Only in the USA and is not FDA cleared for clinical diagnostic use. SlideQC BF is accessed via the HALO AP® enterprise digital pathology platform.
HALO AP® is CE-IVDR marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. HALO AP® is For Research Use Only in the USA and is not FDA cleared for clinical diagnostic use. In addition, HALO AP® provides built-in compliance with FDA 21 CFR Part 11, HIPAA, and GDPR.