SlideQC BF

SlideQC BF for HALO AP® is an automated, AI-powered application for H&E-staineddigitized 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 a quality control tool for whole slide images and is not regulated as a medical device under Regulation EU 2017/746 (IVDR) or MDR 2002 (UK).

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 US and is not FDA cleared for clinical diagnostic use. In addition, HALO AP provides built-in compliance and certifications with FDA 21 CFR Part 11, ISO 13485:2016, HIPAA, and GDPR.