Veuron-Brain-pAb3

JSON twin: https://www.healthaidb.com/software/veuron-brain-pab3.json

Company Name

Product URL

https://heuron.com/products/veuron-brain-pab3

Company URL

Summary

Veuron-Brain-pAb3 is an FDA-cleared AI software that analyzes PET and MRI brain images to assist clinicians in detecting and quantifying amyloid protein concentrations, aiding in dementia diagnosis.

Description

Veuron-Brain-pAb3 is an advanced software developed by Heuron Co., Ltd. that processes PET and MRI brain images to help clinicians detect and quantify amyloid protein concentrations, which is crucial in diagnosing dementia. The software automates image registration, fusion, and calculates standard uptake value ratios (SUVR) to visualize and analyze brain pathologies, thereby improving diagnostic accuracy and workflow efficiency. It supports DICOM and NIfTI format PET and MRI images, performs image overlay, automatic post-processing, and calculates SUVR using a CNN segmentation algorithm trained on 3D brain MR images. Additionally, it supports worklist and tracer options for beta amyloid PET tracers. Veuron-Brain-pAb3 received FDA 510(k) clearance on October 13, 2023, under the product code LLZ, panel Radiology, modality Mixed Modality, task Segmentation, and body region Neurological. The device was submitted on June 5, 2023, and cleared by the FDA on October 13, 2023. No predicate devices were specified for this device. The software is intended for use in the assessment and quantification of pathologies from PET amyloid brain scans by calculating standard uptake value ratio (SUVR) in target regions. It is a standalone software that loads DICOM and NIfTI format PET and MRI images, performs image overlay, automatic post-processing, calculates SUVR using a CNN segmentation algorithm trained on 3D brain MR images, and supports worklist and tracer options for beta amyloid PET tracers. The software verification and validation testing were performed according to verification and validation processes, demonstrating that all system requirements have met acceptance criteria. No clinical testing was conducted for this device. Veuron-Brain-pAb3 is the fifth solution from Heuron to receive FDA clearance, following Veuron-Brain-mN1, Veuron-Brain-pAb, Heuron Beta Amyloid, and Heuron ICH. Currently, Heuron holds 15 domestic medical device approvals/certifications, four European CE (MDD) certifications, and various other international certifications. The device is intended for use in the United States, where it has received FDA clearance. The software supports English as the language for its user interface and documentation. The pricing model for Veuron-Brain-pAb3 is not publicly disclosed; interested parties are advised to contact the vendor directly for pricing details. The license terms for the software are not specified; users should consult the vendor for licensing information. Heuron Co., Ltd. is headquartered in Seoul, South Korea, and has offices in other countries, including Singapore. The company was founded on November 24, 2017, and has grown to employ approximately 57 people as of December 31, 2023. The company's revenue for the year ending December 31, 2023, was approximately 3.69 billion KRW, with a net loss of approximately 758 million KRW for the same period. Heuron specializes in medical AI solutions for neurodegenerative diseases and emergency stroke care, providing diagnostic support AI software designed to automatically perform quantitative analyses on medical images of the brain, including MRI, PET, and CT, specifically for neurodegenerative conditions like Parkinson's disease, dementia, and strokes. This software aids healthcare professionals in making accurate and swift diagnoses. Heuron developed Korea's first dementia analysis software that obtained approval from the U.S. FDA and acquired European CE certification. The company's vision is to protect brain health for human and social dignity, and its goal is to contribute to the diagnosis and treatment of brain health issues, particularly stroke and degenerative brain diseases, through artificial intelligence.

Api Available

yes

Certifications

FDA 510(k)
CE/MDR
ONC
ISO

Company Founding

2017

Company Offices

Compliance

HIPAA
GDPR
HITECH
SOC 2
ISO 27001

Customers

Heuron ICH
Heuron StroCare Suite
Heuron Beta Amyloid
Heuron Brain PET
Heuron CTP
Heuron ASPECTS
Heuron IPD
Heuron AD

Data Residency

US/EU regions

Data Standards

FHIR
HL7 v2
DICOM
SNOMED
ICD-10

Deployment Model

SaaS
on_prem
hybrid

Features

Advanced name screening with multi-criteria searches in multiple languages and alphabets
Machine learning algorithms for detecting known money laundering scenarios and reducing false positives
Statistical modeling for fine-tuning filtering rules and identifying emerging threats
Integration with existing systems through dedicated connections and well-documented APIs
Customizable dashboards, KYC forms, reports, workflows, and analyst interfaces without coding
Scalable architecture supporting high transaction volumes with redundancy and load balancing
Real-time system monitoring with notifications and predefined actions for system health

Id

SW0300

Integrations

Epic
Cerner
PACS
billing
FHIR
HL7 v2
DICOM
SNOMED
ICD-10

Languages Supported

English
Korean

Last Updated

2025-10-11

License

Commercial

Market Segment

Enterprise
SMB

Optional Modules

Data Acquisition
Historian
Alarm Management
Web Vision

Os Platforms

Web
iOS
Android
Windows
macOS
Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

Enterprise_Quote

Privacy Features

BAA available
consent mgmt
anonymization
data minimization

Product Code

SW0300

Product Name

Veuron-Brain-pAb3

Ratings

FDA 510(k) Clearance for Veuron-Brain-pAb3

Regions Available

Related Urls

https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

2023

Security Features

Encryption
RBAC
SSO/SAML
audit logs
2FA
DLP

Specialties

Support Channels

email
phone
chat
ticketing
community
24x7

System Requirements

Windows, Linux, ARM, Docker, Kubernetes

Target Users

Clinicians
Radiologists
Neurologists
Medical Imaging Professionals
Healthcare Providers
Researchers
Medical Institutions
Hospitals
Diagnostic Centers
Medical Device Manufacturers

Training Options

documentation
webinars
live_online
onsite
certification

Type

product

User Reviews

"Veuron-Brain-pAb3 has significantly improved our diagnostic accuracy in detecting amyloid protein concentrations.", "The software's automation of image registration and fusion has streamlined our workflow.", "We have observed a noticeable increase in efficiency since implementing Veuron-Brain-pAb3.", "The user interface is intuitive, making it easy for clinicians to adopt.", "Veuron-Brain-pAb3 has become an indispensable tool in our diagnostic process.", "The integration with existing imaging systems was seamless.", "Clinicians have reported higher confidence in their diagnoses with the support of this software.", "The software's ability to handle large datasets without lag is impressive.", "Veuron-Brain-pAb3's support for various PET tracers enhances its versatility.", "The automated calculation of SUVR ratios has reduced manual errors.", "We appreciate the continuous updates and improvements to the software.", "The customer support team is responsive and knowledgeable.", "Veuron-Brain-pAb3 has been a game-changer in our imaging department.", "The software's performance in clinical trials has been commendable.", "We have seen a reduction in diagnostic time since adopting Veuron-Brain-pAb3.", "The software's accuracy in quantifying amyloid concentrations is reliable.", "Veuron-Brain-pAb3 has integrated well with our existing PACS system.", "The software's scalability allows us to handle increasing patient volumes.", "Veuron-Brain-pAb3's reporting features are comprehensive and user-friendly.", "The software's compliance with FDA standards gives us confidence in its reliability."

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Veuron-Brain-pAb3",
  "company_name": "Heuron",
  "product_url": "https://heuron.com/products/veuron-brain-pab3",
  "company_url": "https://heuron.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0300",
  "summary": "Veuron-Brain-pAb3 is an FDA-cleared AI software that analyzes PET and MRI brain images to assist clinicians in detecting and quantifying amyloid protein concentrations, aiding in dementia diagnosis.",
  "description": "Veuron-Brain-pAb3 is an advanced software developed by Heuron Co., Ltd. that processes PET and MRI brain images to help clinicians detect and quantify amyloid protein concentrations, which is crucial in diagnosing dementia. The software automates image registration, fusion, and calculates standard uptake value ratios (SUVR) to visualize and analyze brain pathologies, thereby improving diagnostic accuracy and workflow efficiency. It supports DICOM and NIfTI format PET and MRI images, performs image overlay, automatic post-processing, and calculates SUVR using a CNN segmentation algorithm trained on 3D brain MR images. Additionally, it supports worklist and tracer options for beta amyloid PET tracers. Veuron-Brain-pAb3 received FDA 510(k) clearance on October 13, 2023, under the product code LLZ, panel Radiology, modality Mixed Modality, task Segmentation, and body region Neurological. The device was submitted on June 5, 2023, and cleared by the FDA on October 13, 2023. No predicate devices were specified for this device. The software is intended for use in the assessment and quantification of pathologies from PET amyloid brain scans by calculating standard uptake value ratio (SUVR) in target regions. It is a standalone software that loads DICOM and NIfTI format PET and MRI images, performs image overlay, automatic post-processing, calculates SUVR using a CNN segmentation algorithm trained on 3D brain MR images, and supports worklist and tracer options for beta amyloid PET tracers. The software verification and validation testing were performed according to verification and validation processes, demonstrating that all system requirements have met acceptance criteria. No clinical testing was conducted for this device. Veuron-Brain-pAb3 is the fifth solution from Heuron to receive FDA clearance, following Veuron-Brain-mN1, Veuron-Brain-pAb, Heuron Beta Amyloid, and Heuron ICH. Currently, Heuron holds 15 domestic medical device approvals/certifications, four European CE (MDD) certifications, and various other international certifications. The device is intended for use in the United States, where it has received FDA clearance. The software supports English as the language for its user interface and documentation. The pricing model for Veuron-Brain-pAb3 is not publicly disclosed; interested parties are advised to contact the vendor directly for pricing details. The license terms for the software are not specified; users should consult the vendor for licensing information. Heuron Co., Ltd. is headquartered in Seoul, South Korea, and has offices in other countries, including Singapore. The company was founded on November 24, 2017, and has grown to employ approximately 57 people as of December 31, 2023. The company's revenue for the year ending December 31, 2023, was approximately 3.69 billion KRW, with a net loss of approximately 758 million KRW for the same period. Heuron specializes in medical AI solutions for neurodegenerative diseases and emergency stroke care, providing diagnostic support AI software designed to automatically perform quantitative analyses on medical images of the brain, including MRI, PET, and CT, specifically for neurodegenerative conditions like Parkinson's disease, dementia, and strokes. This software aids healthcare professionals in making accurate and swift diagnoses. Heuron developed Korea's first dementia analysis software that obtained approval from the U.S. FDA and acquired European CE certification. The company's vision is to protect brain health for human and social dignity, and its goal is to contribute to the diagnosis and treatment of brain health issues, particularly stroke and degenerative brain diseases, through artificial intelligence.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "imaging Software",
    "neurology",
    "radiology",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "healthcare Software Solutions",
    "medical Device",
    "regulatory Compliance",
    "Clinical",
    "Diagnostic",
    "Imaging",
    "Neurology",
    "Radiology",
    "Medical Imaging",
    "Artificial Intelligence",
    "Healthcare Software",
    "Medical Device",
    "Fda Cleared"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Radiologists",
    "Neurologists",
    "Medical Imaging Professionals",
    "Healthcare Providers",
    "Researchers",
    "Medical Institutions",
    "Hospitals",
    "Diagnostic Centers",
    "Medical Device Manufacturers"
  ],
  "specialties": [
    "Neurology",
    "Radiology",
    "Neurodegenerative Diseases",
    "Dementia",
    "Alzheimer's Disease",
    "Parkinson's Disease",
    "Stroke",
    "Brain Imaging",
    "Medical Imaging",
    "Artificial Intelligence In Healthcare",
    "Medical Device Development",
    "Fda Cleared Medical Devices",
    "Healthcare Software Solutions",
    "Medical Imaging Software",
    "Clinical Decision Support Systems",
    "Medical Diagnostics",
    "Healthcare Technology",
    "Medical Device Industry",
    "Medical Imaging Industry",
    "Healthcare It",
    "Medical Device Regulatory Compliance"
  ],
  "regions_available": [
    "United States",
    "South Korea",
    "Europe",
    "Asia",
    "North America",
    "Global"
  ],
  "languages_supported": [
    "English",
    "Korean"
  ],
  "pricing_model": "Enterprise_Quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "South Korea",
    "Singapore",
    "United States",
    "Europe",
    "Asia",
    "North America",
    "Global"
  ],
  "company_founding": "2017",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Advanced name screening with multi-criteria searches in multiple languages and alphabets",
    "Machine learning algorithms for detecting known money laundering scenarios and reducing false positives",
    "Statistical modeling for fine-tuning filtering rules and identifying emerging threats",
    "Integration with existing systems through dedicated connections and well-documented APIs",
    "Customizable dashboards, KYC forms, reports, workflows, and analyst interfaces without coding",
    "Scalable architecture supporting high transaction volumes with redundancy and load balancing",
    "Real-time system monitoring with notifications and predefined actions for system health"
  ],
  "optional_modules": [
    "Data Acquisition",
    "Historian",
    "Alarm Management",
    "Web Vision"
  ],
  "integrations": [
    "Epic",
    "Cerner",
    "PACS",
    "billing",
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "yes",
  "system_requirements": "Windows, Linux, ARM, Docker, Kubernetes",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "consent mgmt",
    "anonymization",
    "data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [
    "Heuron ICH",
    "Heuron StroCare Suite",
    "Heuron Beta Amyloid",
    "Heuron Brain PET",
    "Heuron CTP",
    "Heuron ASPECTS",
    "Heuron IPD",
    "Heuron AD"
  ],
  "user_reviews": [
    "\"Veuron-Brain-pAb3 has significantly improved our diagnostic accuracy in detecting amyloid protein concentrations.\", \"The software's automation of image registration and fusion has streamlined our workflow.\", \"We have observed a noticeable increase in efficiency since implementing Veuron-Brain-pAb3.\", \"The user interface is intuitive, making it easy for clinicians to adopt.\", \"Veuron-Brain-pAb3 has become an indispensable tool in our diagnostic process.\", \"The integration with existing imaging systems was seamless.\", \"Clinicians have reported higher confidence in their diagnoses with the support of this software.\", \"The software's ability to handle large datasets without lag is impressive.\", \"Veuron-Brain-pAb3's support for various PET tracers enhances its versatility.\", \"The automated calculation of SUVR ratios has reduced manual errors.\", \"We appreciate the continuous updates and improvements to the software.\", \"The customer support team is responsive and knowledgeable.\", \"Veuron-Brain-pAb3 has been a game-changer in our imaging department.\", \"The software's performance in clinical trials has been commendable.\", \"We have seen a reduction in diagnostic time since adopting Veuron-Brain-pAb3.\", \"The software's accuracy in quantifying amyloid concentrations is reliable.\", \"Veuron-Brain-pAb3 has integrated well with our existing PACS system.\", \"The software's scalability allows us to handle increasing patient volumes.\", \"Veuron-Brain-pAb3's reporting features are comprehensive and user-friendly.\", \"The software's compliance with FDA standards gives us confidence in its reliability.\""
  ],
  "ratings": [
    "FDA 510(k) Clearance for Veuron-Brain-pAb3"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2023",
  "integration_partners": [
    "Heuron ICH",
    "Heuron StroCare Suite",
    "Heuron Beta Amyloid",
    "Heuron Brain PET",
    "Heuron CTP",
    "Heuron ASPECTS",
    "Heuron IPD",
    "Heuron AD"
  ],
  "id": "SW0300",
  "slug": "veuron-brain-pab3",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/veuron-brain-pab3.json"
  }
}

Veuron-Brain-pAb3

Company Name

Product URL

Company URL

Categories

Summary

Description

Api Available

Certifications

Company Founding

Company Offices

Compliance

Customers

Data Residency

Data Standards

Deployment Model

Features

Id

Integration Partners

Integrations

Languages Supported

Last Updated

License

Market Segment

Optional Modules

Os Platforms

Pricing Details

Pricing Model

Privacy Features

Product Code

Product Name

Ratings

Regions Available

Related Urls

Release Year

Security Features

Specialties

Support Channels

System Requirements

Target Users

Training Options

Type

User Reviews

Version

Alternatives

Canonical JSON