ClearView cCAD

JSON twin: https://www.healthaidb.com/software/clearview-ccad.json

Company Name

ClearView Diagnostics

Product URL

https://www.clearviewdiagnostics.com/clearview-ccad

Company URL

https://www.clearviewdiagnostics.com

Categories

• imaging Software
• radiology
• ai Clinical Documentation Integrity
• clinical Decision Support
• medical Device
• Clinical Imaging
• Diagnostic Imaging
• Medical Imaging
• Artificial Intelligence
• Medical Devices

Summary

ClearView cCAD is an AI-powered software tool designed to assist radiologists in analyzing breast ultrasound images for early detection of breast cancer.

Description

ClearView cCAD utilizes deep learning techniques to automatically classify lesion shape and orientation in breast ultrasound images, generating reports compliant with ACR BI-RADS standards. It operates as a web service on Windows platforms, accepting DICOM images and aiding radiologists in their assessment without replacing primary diagnostic interpretation. The software received FDA clearance in December 2016 and has demonstrated accuracy comparable to MQSA-certified radiologists in discerning BI-RADS characteristics across over 1,200 cases.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• CE mark
• ISO 13485
• ISO 9001
• ISO 14971
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21

Company Founding

2012

Company Offices

• United States

Compliance

• FDA 510(k) clearance
• HIPAA
• FDA regulations
• Medical device regulations
• Clinical trial regulations
• Data protection laws
• Medical device standards
• Healthcare compliance standards
• Medical device safety standards
• Medical device quality standards
• Medical device labeling requirements
• Medical device reporting requirements
• Medical device adverse event reporting
• Medical device post-market surveillance
• Medical device recalls
• Medical device adverse event reporting requirements
• Medical device adverse event reporting guidelines
• Medical device adverse event reporting forms
• Medical device adverse event reporting procedures
• Medical device adverse event reporting regulations

Customers

Data Residency

US-only

Data Standards

• DICOM
• HL7 v2
• FHIR
• SNOMED
• ICD-10
• LOINC
• CPT
• ICD-9
• HL7 CDA
• HL7 CCD

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• AI-powered breast ultrasound image analysis
• Automatic classification of lesion shape and orientation
• Generation of BI-RADS compliant reports
• Assistance in early detection and accurate diagnosis of breast cancer
• Integration with DICOM images
• Web service-based architecture
• User selection of regions of interest for analysis
• DICOM compatible reporting generation
• High-resolution display support
• Processing speed optimization
• Reduction of unnecessary biopsies
• Improvement of diagnostic accuracy
• Support for multiple cancer and disease types
• Integration with mobile devices
• Enhanced diagnostic productivity
• Clinical smartphone device compatibility
• Assistance in early detection of diseases
• Improvement of patient outcomes
• Quality of life enhancement
• Support for hospital staff connectivity

Id

SW0616

Integration Partners

Integrations

• Honeywell Dolphin CT50h mobile computer
• DICOM-compatible systems
• Mobile devices
• Hospital IT infrastructure
• Clinical smartphone devices
• Diagnostic imaging systems
• Radiology workstations
• Medical imaging devices
• Healthcare IT systems
• Hospital information systems
• Electronic health records (EHR) systems
• Picture archiving and communication systems (PACS)
• Medical imaging software
• Diagnostic equipment
• Medical devices
• Healthcare applications
• Clinical decision support systems
• Medical imaging platforms
• Healthcare software solutions
• Medical imaging technologies

Languages Supported

• English

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• ClearView cCAD on Honeywell Dolphin CT50h mobile computer

Os Platforms

• Windows

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• Business Associate Agreement (BAA)
• Data anonymization
• Data minimization
• Data masking
• Data pseudonymization
• Data segregation
• Data retention policies
• Data access controls
• Data sharing policies
• Data subject rights management

Product Code

SW0616

Product Name

ClearView cCAD

Ratings

Regions Available

• United States

Related Urls

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

Release Year

Security Features

• Encryption
• Role-based access control (RBAC)
• Audit logs
• Secure data transmission
• Data integrity checks
• User authentication
• Data backup
• Data recovery
• Data redundancy
• Data access controls

Specialties

• Radiology
• Oncology
• Medical Imaging

Support Channels

System Requirements

Windows OS, DICOM-compatible systems, Mobile devices, Hospital IT infrastructure, Clinical smartphone devices, Diagnostic imaging systems, Radiology workstations, Medical imaging devices, Healthcare IT systems, Hospital information systems, Electronic health records (EHR) systems, Picture archiving and communication systems (PACS), Medical imaging software, Diagnostic equipment, Medical devices, Healthcare applications, Clinical decision support systems, Medical imaging platforms, Healthcare software solutions, Medical imaging technologies

Target Users

• Radiologists
• Clinicians
• Medical Imaging Professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "ClearView Diagnostics",
  "product_url": "https://www.clearviewdiagnostics.com/clearview-ccad",
  "company_url": "https://www.clearviewdiagnostics.com",
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  "product_code": "SW0616",
  "summary": "ClearView cCAD is an AI-powered software tool designed to assist radiologists in analyzing breast ultrasound images for early detection of breast cancer.",
  "description": "ClearView cCAD utilizes deep learning techniques to automatically classify lesion shape and orientation in breast ultrasound images, generating reports compliant with ACR BI-RADS standards. It operates as a web service on Windows platforms, accepting DICOM images and aiding radiologists in their assessment without replacing primary diagnostic interpretation. The software received FDA clearance in December 2016 and has demonstrated accuracy comparable to MQSA-certified radiologists in discerning BI-RADS characteristics across over 1,200 cases.",
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    "Radiology",
    "Artificial Intelligence",
    "Medical Devices"
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  "market_segment": [
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  "target_users": [
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  "specialties": [
    "Radiology",
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  "regions_available": [
    "United States"
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  "languages_supported": [
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  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
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  "company_founding": "2012",
  "deployment_model": [
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    "Assistance in early detection and accurate diagnosis of breast cancer",
    "Integration with DICOM images",
    "Web service-based architecture",
    "User selection of regions of interest for analysis",
    "DICOM compatible reporting generation",
    "High-resolution display support",
    "Processing speed optimization",
    "Reduction of unnecessary biopsies",
    "Improvement of diagnostic accuracy",
    "Support for multiple cancer and disease types",
    "Integration with mobile devices",
    "Enhanced diagnostic productivity",
    "Clinical smartphone device compatibility",
    "Assistance in early detection of diseases",
    "Improvement of patient outcomes",
    "Quality of life enhancement",
    "Support for hospital staff connectivity"
  ],
  "optional_modules": [
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    "DICOM-compatible systems",
    "Mobile devices",
    "Hospital IT infrastructure",
    "Clinical smartphone devices",
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    "Radiology workstations",
    "Medical imaging devices",
    "Healthcare IT systems",
    "Hospital information systems",
    "Electronic health records (EHR) systems",
    "Picture archiving and communication systems (PACS)",
    "Medical imaging software",
    "Diagnostic equipment",
    "Medical devices",
    "Healthcare applications",
    "Clinical decision support systems",
    "Medical imaging platforms",
    "Healthcare software solutions",
    "Medical imaging technologies"
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  "data_standards": [
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    "HL7 v2",
    "FHIR",
    "SNOMED",
    "ICD-10",
    "LOINC",
    "CPT",
    "ICD-9",
    "HL7 CDA",
    "HL7 CCD"
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  "api_available": "unknown",
  "system_requirements": "Windows OS, DICOM-compatible systems, Mobile devices, Hospital IT infrastructure, Clinical smartphone devices, Diagnostic imaging systems, Radiology workstations, Medical imaging devices, Healthcare IT systems, Hospital information systems, Electronic health records (EHR) systems, Picture archiving and communication systems (PACS), Medical imaging software, Diagnostic equipment, Medical devices, Healthcare applications, Clinical decision support systems, Medical imaging platforms, Healthcare software solutions, Medical imaging technologies",
  "compliance": [
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    "FDA regulations",
    "Medical device regulations",
    "Clinical trial regulations",
    "Data protection laws",
    "Medical device standards",
    "Healthcare compliance standards",
    "Medical device safety standards",
    "Medical device quality standards",
    "Medical device labeling requirements",
    "Medical device reporting requirements",
    "Medical device adverse event reporting",
    "Medical device post-market surveillance",
    "Medical device recalls",
    "Medical device adverse event reporting requirements",
    "Medical device adverse event reporting guidelines",
    "Medical device adverse event reporting forms",
    "Medical device adverse event reporting procedures",
    "Medical device adverse event reporting regulations"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE mark",
    "ISO 13485",
    "ISO 9001",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21"
  ],
  "security_features": [
    "Encryption",
    "Role-based access control (RBAC)",
    "Audit logs",
    "Secure data transmission",
    "Data integrity checks",
    "User authentication",
    "Data backup",
    "Data recovery",
    "Data redundancy",
    "Data access controls"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA)",
    "Data anonymization",
    "Data minimization",
    "Data masking",
    "Data pseudonymization",
    "Data segregation",
    "Data retention policies",
    "Data access controls",
    "Data sharing policies",
    "Data subject rights management"
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  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0616",
  "slug": "clearview-ccad",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
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}