Aperio iQC DX

by Leica Biosystems  · Based in Germany → — AI-Powered Whole Slide Imaging Quality Control
Laboratory Medicine Pathology
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Overview

Aperio iQC DX software is the first FDA 510(k)-cleared software for AI-assisted digital pathology quality control. It is designed to identify artifacts during tissue preparation, staining, coverslipping, or scanning, such as air bubbles, pen marks, clipped tissue, missing tissue, out-of-focus regions, and image striping. This AI-powered quality control solution integrates seamlessly with the Aperio GT series of scanners, providing rapid, automated artifact detection and alerts directly on the scanner console while slides are still being scanned. By identifying issues early in the workflow, laboratories can reduce whole slide image (WSI) review time, reallocate skilled staff to higher-value tasks, and improve overall lab efficiency. The software aims to transform quality control in digital pathology from a manual, subjective task into a streamlined, automated, and reproducible process.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered automated artifact detection (six common issues)
  • Seamless integration with Aperio GT series scanners
  • Real-time alerts on scanner console
  • Centralized dashboard with visual indicators for rapid review
  • Reduces histotechnician QC time by up to 69%
  • Detects up to 24% more artifacts missed by histotechnicians
  • Standardizes QC processes across users and shifts
  • Provides quality metrics for lab tissue/digital preparation
  • Automatic rescan functionality for digital artifacts
  • Supports H&E and IHC stained slides in SVS and DICOM formats

Use Cases

  • Automated quality control in digital pathology workflows
  • Early identification and resolution of slide artifacts
  • Reducing manual whole slide image review time
  • Improving lab efficiency and staff reallocation
  • Standardizing quality control processes in clinical pathology labs
  • Enhancing confidence in slide quality for clinical diagnosis

What Physicians Need to Know

LIS/LIMS Integration
The Aperio iQC DX software offers fast and easy LIS/LIMS integration utility to provide interoperability. It enables seamless integration with your LIS via automated data translation and automated bidirectional communication to streamline workflows. The LIS remains the central hub for case dispatching, launching Aperio Viewers, and reporting. It also supports hub and spoke connectivity from a single LIS.
Supported Assay Types
The Aperio iQC DX software automatically checks scanned H&E and IHC slides.
QC/QA Features
Aperio iQC DX is the first FDA 510(k)-cleared software for AI-assisted digital pathology quality control in a clinical setting. It automatically detects six common quality issues in whole slide images (WSIs) while slides are still on the scanner: air bubbles, pen marks, clipped tissue, missing tissue, out-of-focus regions, and image striping. Pop-up alerts are displayed on the scanner console, and a centralized dashboard with visual indicators allows for rapid artifact review and assessment. The software also provides quality metrics for lab tissue/digital preparation and standardizes QC processes across users and shifts, reducing variability. When digital artifacts are detected, connected scanners can automatically initiate a rescan with optimized parameters to resolve issues.
Result Interpretation AI
The software utilizes AI-powered detection to identify histological or scanning artifacts. In a real-world study, the AI models detected up to 24% more artifacts missed by histotechnicians.
Critical Value Alerts
Pop-up alerts are displayed on the scanner console when quality issues are detected, allowing for early intervention before slides are removed from the scanner.
Instrument Interfaces
Aperio iQC DX software is seamlessly integrated with the Aperio GT series of scanners (Aperio GT 450 DX, Aperio GT 180 DX, and Aperio GT Elite). It supports DICOM and SVS image formats.
Turnaround Time Impact
The software reduces histotechnician QC time by up to 69%, freeing up skilled personnel for higher-value tasks and accelerating turnaround times. By identifying and resolving quality concerns earlier in the workflow, it reduces the need for rescanning and minimizes downstream delays.
Physician Tip

Aperio iQC DX significantly enhances the reliability of digital pathology slides by automating quality control and flagging common artifacts early in the scanning process. This leads to more consistent and accurate whole slide images, which can improve diagnostic confidence and reduce the need for manual re-reviews. The system's ability to identify issues like out-of-focus regions or missing tissue before pathologist review helps ensure that only high-quality images are presented for diagnosis, ultimately supporting faster and more confident patient care decisions.

The Aperio iQC DX software is designed for tight integration within the Leica Biosystems digital pathology ecosystem, particularly with the Aperio GT series scanners. Its compatibility with HL7 and DICOM standards facilitates integration with existing LIS, LIMS, or PACS systems, ensuring a streamlined workflow for data and image management. The system is built with a secure, scalable IT architecture, including cybersecurity controls and dedicated logins, to support various laboratory configurations.

Details

Category Lab & Diagnostics, Pathology AI
Pricing Unknown — Contact Leica Biosystems for a quote.
DeploymentOn-premise (installed on customer's server)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Unknown AI-estimated

Aperio iQC DX software is the first FDA 510(k)-cleared software for AI-assisted digital pathology quality control in a clinical setting. It identifies artifacts created during tissue preparation, staining, coverslipping, or scanning.
Integrations
EHR Not specified
Specialties Laboratory Medicine, Pathology

What the Web Says

Aperio iQC DX is an AI-powered software designed to automate quality control in digital pathology workflows, primarily for use with Leica Biosystems' Aperio GT scanner series. It aims to transform manual, subjective quality control into a streamlined, automated process by detecting common histological and scanning artifacts early in the workflow. This system is intended to improve efficiency, reduce review time for histotechnicians, and enhance overall slide quality and consistency in clinical pathology labs.

Overall: Positive

Strengths

  • Automated detection of common histological and scanning artifacts (e.g., air bubbles, pen marks, clipped tissue, missing tissue, out-of-focus regions, image striping).
  • Reduces hands-on time for histotechnician review by up to 69%.
  • Identifies more artifacts (up to 24%) than manual review alone.
  • Integrates seamlessly with Aperio GT scanners, providing alerts while slides are still on the scanner.
  • Enhances operational efficiency and allows reallocation of skilled staff to higher-value tasks.
  • Improves consistency and standardization of whole slide image (WSI) quality control, reducing subjectivity.

Limitations

  • Requires integration with Aperio GT scanner series.
  • Some users of Aperio systems (not specifically iQC DX) have reported complications with full capacity usage and issues with fresh slides needing to be completely dry.
  • Previous Aperio image analysis software (not specifically iQC DX) had issues with DAPI artifacts on ICC.
  • The cost of Leica's digital pathology systems, including AI add-ons, can be substantial.
  • All images must still be reviewed by the user, despite AI assistance.
  • Limited availability in research centers for some Aperio products (not specifically iQC DX).

Based on reviews from: Leica Biosystems, LabMedica, PR Newswire, Clinical Lab Products, The Scientist, Technology Networks, BioSpace, MLO Online, Capterra, Reddit

Last updated: 2026-08-28

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Press & Coverage

PR Newswire
Leica Biosystems Expands Clinical Digital Pathology Portfolio with Multiple Launches at DPAI 2025
Leica Biosystems introduced Aperio iQC DX software at the Digital Pathology and AI (DPAI) Congress in London, a breakthrough in digital pathology quality control designed to streamline slide QC processes and reduce variability.
2025-12
MLO Online
Leica Biosystems receives multiple FDA clearances for digital pathology
Leica Biosystems announced multiple U.S. FDA 510(k) clearances, including for Aperio iQC DX, which is described as the industry's first FDA-cleared AI software for real-time quality control in digital pathology.
2026-08
LabMedica
AI Tool Identifies Slide Artifacts to Speed Digital Pathology Diagnosis
Aperio iQC DX is the first standalone AI-assisted quality control software for clinical digital pathology, analyzing whole-slide images on the scanner to automatically flag common artifacts and reduce rescanning.
2026-08
Clinical Lab Products
Leica Biosystems Receives FDA Clearances for AI-Assisted Quality Control and Digital Pathology Scanners
Leica Biosystems received multiple FDA 510(k) clearances, including for the Aperio iQC DX software, which is the first FDA-cleared software for AI-assisted digital pathology quality control in a clinical setting.
2026-08
Leica Biosystems
Leica Biosystems Enables Faster Cancer Diagnoses Through Multiple Digital Pathology FDA Clearances, Including Industry-First AI-Assisted Quality Control Software
Leica Biosystems announced FDA 510(k) clearances for Aperio iQC DX software, the Aperio GT 180 DX scanner, and enhanced Aperio GT 450 DX scanner capabilities, reinforcing their commitment to connected, standardized, and scalable clinical workflows.
2026-08
Hospital & Healthcare Management
Leica Biosystems Secures FDA Clearances to Expand Digital Pathology Portfolio
Leica Biosystems received multiple FDA 510(k) clearances, including for the Aperio iQC DX software, which is the industry's first FDA 510(k)-cleared AI-assisted quality control software for digital pathology in a clinical environment.
2026-08
Labcompare
Leica Biosystems Launches New Digital Pathology Scanner and QC Software
Leica Biosystems unveiled the Aperio iQC DX software at the Digital Pathology and AI Congress in London, marking their entry into automated quality control for digital pathology by standardizing QC processes and automating artifact detection.
2025-12
PathologyOutlines.com
FDA Grants Clearance to Leica Biosystems' Digital Pathology Products
The FDA 510(k)-cleared Aperio iQC DX software is the industry's first AI-assisted digital pathology quality control software in a clinical setting, designed to accelerate diagnosis by detecting artifacts early in the workflow.
2026-08

Videos

Product demos, reviews, and walkthroughs for Aperio iQC DX.

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Frequently Asked Questions

Aperio iQC DX is an AI-powered software designed for automated quality control of whole slide images in digital pathology. It identifies common artifacts like air bubbles, pen marks, and out-of-focus regions early in the workflow, reducing manual review time by up to 69% and improving overall slide quality and consistency.
Yes, Aperio iQC DX software is FDA 510(k)-cleared for AI-assisted digital pathology quality control in a clinical setting in the U.S.. It also carries CE marking under the In Vitro Diagnostic Regulation for diagnostic use in other regions.
Aperio iQC DX seamlessly integrates with Aperio GT series scanners, detecting artifacts while slides are still on the scanner and providing alerts. This early detection minimizes rescanning, reduces downstream delays, and allows histotechnicians to reallocate time to higher-value tasks, enhancing operational efficiency and diagnostic confidence.
While Aperio iQC DX significantly automates artifact detection, all images must still be reviewed by a user. The software is designed to augment, not entirely replace, manual quality control processes, and its effectiveness is based on detecting six common types of artifacts.
While Aperio iQC DX is noted as the industry's first FDA 510(k)-cleared standalone AI-assisted quality control software for clinical digital pathology, other companies may offer digital pathology solutions with varying levels of integrated quality control features. However, specific direct alternatives with the same FDA clearance for AI-assisted QC are not detailed in the provided information.
By automatically detecting and categorizing histological and scanning artifacts, Aperio iQC DX helps standardize QC processes across users and shifts, reducing variability. This leads to more consistent and reproducible image review, supporting pathologists in delivering more reliable decisions and better patient outcomes.
The Aperio GT 180 DX scanner, which integrates with Aperio iQC DX, is described as easy-to-use with limited training required. For specific details on training programs and technical support for Aperio iQC DX software, it would be best to contact Leica Biosystems directly.

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Suggest an Edit → | Last Verified: 2026-08-23 | First Added: 2026-08-23
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