HEURON IPD

INTENDED PURPOSE

Heuron IPD is a diagnostic aid software to assist medical professionals in diagnosing neurodegenerative Parkinson's disease by analyzing nigrosome 1 MR images and clinical information of neurodegenerative Parkinson's disease patients and normal people taken through nigrosome 1 imaging protocol.

INTENDED USER

Medical professional

INDICATIONS FOR USE

Patients with suspected neurodegenerative Parkinson's disease.

CONTRAINDICATIONS

Heuron IPD has no patient-specific clinical contraindications.

WARNINGS

Images provided with the product are for informational purposes only and are not intended for diagnostic use. Clinical decisions must be made by qualified medical professionals.

RESIDUAL RISKS

All identified risks have been reduced to an acceptable level, and no additional risks associated with the intended use have been detected (based on ISO 14971 risk management).

PERFORMANCE DATA

Sensitivity: ≥ 93.3% (95% CI: 0.867-0.983 | Specificity: ≥ 95% (95% CI: 0.9-0.985)
(based on internal performance evaluation)
Provides objective, AI-driven diagnostic insights.

SYSTEM REQUIREMENTS

Server PC must have at least 1TB of hard disk capacity, 64GB of available RAM, and 12GB of dedicated GPU memory. Make sure the program is connected to the network environment before running.

HEURON ICH

INTENDED PURPOSE

Heuron ICH is a radiological computer-aided triage and notification software designed to aid medical specialists and hospital networks in streamlining workflow by identifying and communicating suspected positive findings of Intracranial hemorrhage (ICH) using an artificial intelligence algorithm.

INTENDED USER

Medical professional

INDICATIONS FOR USE

Adults or transitional adolescents aged 18 and older suspected of having intracranial hemorrhage (Detection and prioritization based on non-contrast head CT images).

CONTRAINDICATIONS

Heuron ICH has no patient-specific clinical contraindications.

WARNINGS

Compressed preview images are provided for informational purposes only and are not intended for diagnostic use beyond notification. Notified medical specialists are responsible for viewing the full non-contrast CT images in accordance with established standard of care practices. [Scanner Limitation] When using a Siemens scanner, slice thickness must be reconstructed to 2.5-5mm; images outside this range will be automatically excluded from the analysis. [AI Limitation] Errors may occur due to unlearned types or institutional differences, as the algorithm was developed using specific training data (e.g., RSNA dataset).

RESIDUAL RISKS

All identified risks have been reduced to an acceptable level, and no additional risks associated with the intended use have been detected (based on ISO 14971 risk management).

PERFORMANCE DATA

Sensitivity: 86.3% (95% CI: 81.9-90.3) | Specificity: 87.6% (95% CI: 83.9-91.0)
Provides the clinical benefit of reducing patient diagnosis time.

SYSTEM REQUIREMENTS

Server PC must have at least 1TB of hard disk capacity, 64GB of available RAM, and 12GB of dedicated GPU memory. A wired network environment is recommended. Appropriate anti-virus and firewall settings must be installed on the server prior to use.

HEURON ELVO

INTENDED PURPOSE

Heuron ELVO is a diagnostic aid software intended to assist medical personnel by automatically analyzing brain non-contrast computed tomography (NCCT) images using a deep learning-based algorithm to classify patients with suspected Large Vessel Occlusion (LVO) for quick diagnosis and treatment decisions.

INTENDED USER

Medical professional

INDICATIONS FOR USE

Patients with suspected Large Vessel Occlusion (LVO).

CONTRAINDICATIONS

Heuron ELVO has no patient-specific clinical contraindications.

WARNINGS

The classifying results cannot determine an LVO patient by themselves. Further investigation of the patient is required for diagnosis.
As this product is intended as a diagnostic aid, clinical decisions must not be made solely based on the results of the device without the judgment of qualified medical personnel.
[AI Limitation] Errors may occur due to unlearned types or institutional differences, as the algorithm was developed using learning data of 411 cases collected from a single institution.

RESIDUAL RISKS

All identified risks have been reduced to an acceptable level, and no additional risks associated with the intended use have been detected (based on ISO 14971 risk management).

PERFORMANCE DATA

Sensitivity: 80% | Specificity: 80%

SYSTEM REQUIREMENTS

PC must have at least 1 GB of hard disk capacity, 8 GB of available RAM, and 4 GB of dedicated GPU memory. Must be connected to a network environment before running. Connect only one Client PC to one Server PC. Do not delete files in the installation path or re-install older versions after an update.

HEURON ASPECTS

INTENDED PURPOSE

Heuron ASPECTS is a diagnostic aid software that automatically analyzes brain non-contrast computed tomography (NCCT) images using a deep learning-based CNN algorithm to provide the Alberta Stroke Program Early CT Score (ASPECTS) to assist medical personnel in diagnosing ischemic stroke.

INTENDED USER

Medical professional

INDICATIONS FOR USE

Patients with suspected ischemic stroke.

CONTRAINDICATIONS

Heuron ASPECTS has no patient-specific clinical contraindications.

WARNINGS

The ASPECTS score cannot determine an ischemic stroke by itself. Further investigation of the patient is required for diagnosis.
As this product is intended as a diagnostic aid, clinical decisions must not be made solely based on the results of the device without the judgment of qualified medical personnel.
[AI Limitation] Errors may occur due to unlearned types or institutional differences, as the algorithm was developed using learning data of 758 cases (379 patients) collected from a single institution.

RESIDUAL RISKS

All identified risks have been reduced to an acceptable level, and no additional risks associated with the intended use have been detected (based on ISO 14971 risk management).

PERFORMANCE DATA

Clinical investigation results showed a score difference average of 0.03, with an upper LOA of 3.11 and a lower LOA of -3.01.

SYSTEM REQUIREMENTS

The server PC requires at least 10GB of hard disk capacity, 16GB of available RAM, 8GB of dedicated GPU memory, and Ubuntu with Docker, Nvidia-docker2, Docker-compose packages, and an appropriate Nvidia graphics driver installed. The client PC requires at least 10GB of hard disk capacity and 8GB of available RAM. The program must be connected to a network environment before running, with only one client PC connected to one server PC. Users must not delete files in the installation path or reinstall older versions after an update.