ClearView cCAD

by ClearView Diagnostics  · Based in United States → — AI-powered computer-aided diagnosis for breast ultrasound.
General Surgery Oncology Radiology
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Regulatory Status Disclosed

Overview

ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. It automatically classifies shape and orientation characteristics of user-selected regions of interest (ROIs) using multivariate pattern recognition methods. The software enables users to annotate, tag, measure, and automatically record and/or store selected views. It also generates reports from user inputs annotated during the image analysis process, as well as from automatically generated characteristics.

Based on core BI-RADS models and lesion characteristic extraction algorithms, ClearView cCAD is a platform-agnostic web service that queries and accepts DICOM compliant digital medical files from ultrasound devices, other DICOM sources, or PACS servers. The tool leverages deep learning techniques to help radiologists analyze large amounts of data, primarily focused on breast cancer diagnosis, with the potential to extend to other cancers and diseases. Notably, ClearView Diagnostics Inc. was rebranded as Koios Medical, and the software is now known as Koios™ DS.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Assists physicians in analyzing breast ultrasound images
  • Automatically classifies shape and orientation characteristics of user-selected regions of interest (ROIs)
  • Utilizes multivariate pattern recognition methods
  • Allows user annotation, tagging, measurement, and storage of views
  • Automatically generates reports from user inputs
  • Based on core BI-RADS models and lesion characteristic extraction algorithms
  • Queries and accepts DICOM compliant digital medical files from various sources (ultrasound, PACS)
  • Aims to reduce unnecessary biopsies by identifying benign conditions
  • Employs deep learning and artificial intelligence techniques
  • Platform-agnostic web service

Use Cases

  • Breast cancer diagnosis from ultrasound images
  • Reducing the number of unnecessary breast biopsies
  • Assisting radiologists in the interpretation of diagnostic images
  • Facilitating compliance with ACR BI-RADSu00ae assessment
  • Potential future application in lung, liver, prostate, and cardiovascular disease diagnosis

What Physicians Need to Know

Key Capabilities
ClearView cCAD is a software application designed to assist physicians in analyzing breast ultrasound images. It automatically classifies shape and orientation characteristics of user-selected regions of interest (ROIs) using multivariate pattern recognition methods. The software allows for annotation, tagging, measuring, and recording/storing of selected views, and automatically generates reports. It is based on core BI-RADS models and lesion characteristic extraction algorithms, incorporating statistical, texture, shape, and orientation descriptors, along with physician input, to aid in ACR BI-RADSu00ae assessment. The system aims to reduce image analysis time, improve diagnostic accuracy, and potentially decrease unnecessary biopsies by helping distinguish between malignant and benign conditions.
Clinical Utility
ClearView cCAD provides information useful for breast ultrasound screening and diagnosis, supporting compliance with the ACR BI-RADSu00ae Ultrasound Lexicon Classification Form. It is intended to assist skilled physicians, not to be the sole basis for patient management decisions. The tool leverages machine learning to help correct radiologist biases and has shown potential to accurately identify breast cancers while significantly reducing benign breast lesions recommended for biopsy.
Integration Options
The ClearView cCAD processing software is a platform-agnostic web service that can query and accept DICOM compliant digital medical files from ultrasound devices, other DICOM sources, or PACS servers. It operates on standard off-the-shelf hardware running Windows 7 or higher or Windows Embedded platforms with network, Microsoft IIS, and Microsoft SQL support. It was also integrated with Honeywell's Dolphin CT50h mobile computer and, as a GE Health Cloud Innovation Challenge winner, had the potential to be hosted on GE Healthcare's cloud platform.
Compliance Status
ClearView cCAD, Version 1.1.0, received FDA 510(k) clearance in December 2016 as a Class II medical device (21 CFR 892.2050, LLZ). Its successor, Koiosu2122 DS (formerly Clearview CAD software), also received 510(k) clearance in January 2017. The system is designed to support compliance with the ACR BI-RADSu00ae Ultrasound Lexicon Classification Form.
User Experience
The software features a user-friendly interface where physicians can select regions of interest by clicking and dragging a bounding box. It allows for annotation, tagging, measuring, and recording of views, with all fields modifiable by the user. The results are displayed to the user, and the system aims for efficient data display.
Implementation Complexity
ClearView cCAD is a software package designed to run on standard, off-the-shelf hardware and does not require specialized equipment. It is compatible with Windows 7 or higher or Windows Embedded platforms, requiring network, Microsoft IIS, and Microsoft SQL support. The processing software functions as a platform-agnostic web service.
Evidence Base
The device's performance has been tested for agreement against MQSA certified radiologists and was found to be as effective as a radiologist's performance without automatic lesion segmentation. It was deemed substantially equivalent to the predicate device BCAD (K050846). An NIH-funded study conducted at USC and UCLA demonstrated 100% accuracy in identifying breast cancers and a 70% reduction in benign breast lesions going to biopsy. The system was developed with a grant from the NIH National Cancer Institute and the Dr. Susan Love Foundation, and as of 2017, was being evaluated with University Radiology Group.
Physician Tip

ClearView cCAD (now Koiosu2122 DS) is a valuable AI-powered assistant for breast ultrasound analysis, particularly for classifying ROIs and supporting BI-RADSu00ae assessment. Remember that while it enhances diagnostic accuracy and efficiency, it's a decision-support tool; final patient management decisions should always integrate the physician's expertise and comprehensive clinical context. Its ability to reduce unnecessary biopsies is a significant benefit for both patients and healthcare systems. Pay attention to the clarity of the displayed results and ensure proper integration with your existing PACS and ultrasound equipment for optimal workflow. Leverage its reporting features for standardized documentation.

ClearView cCAD is designed for broad compatibility, functioning as a DICOM-compliant web service that integrates with various ultrasound devices, DICOM sources, and PACS systems. Its ability to run on standard Windows platforms with common server software (IIS, SQL) suggests a relatively straightforward IT setup. The past integration with Honeywell mobile devices and potential for GE Health Cloud hosting indicates a flexible architecture open to diverse deployment environments. Ensure your IT infrastructure meets the specified Windows and database requirements for seamless operation.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Not available — Not available
DeploymentPlatform-agnostic web service, requires Windows 7 or higher or Windows Embedded platform with network, Microsoft IIS, and Microsoft SQL support.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

ClearView cCAD, Version 1.1.0, received 510(k) clearance (K161959) from the FDA on December 28, 2016. It is classified as a Class II medical device (Image Processing System, product code LLZ) intended to assist skilled physicians in analyzing breast ultrasound images.
Integrations
EHR Not specified
Specialties General Surgery, Oncology, Radiology

What the Web Says

ClearView cCAD is a computer-aided detection system for mammography, designed to assist radiologists in identifying potential abnormalities. Reviews indicate it aims to improve diagnostic accuracy and efficiency in breast cancer screening. While the official website highlights its benefits, independent reviews from physicians and tech platforms are somewhat limited or not widely publicized, making a comprehensive sentiment analysis challenging.

Overall: Mixed

Strengths

  • Aids in early detection of breast cancer
  • Designed to improve diagnostic accuracy
  • Potentially increases radiologist efficiency
  • Non-invasive diagnostic support tool
  • Integrates with existing mammography workflows
  • Reduces inter-observer variability

Limitations

  • Limited independent, in-depth physician reviews publicly available
  • Specific efficacy data from large-scale independent studies is not easily found
  • Potential for over-reliance on CAD systems
  • Cost of implementation and maintenance unknown
  • Learning curve for new users (radiologists and technicians)
  • May not be universally adopted across all healthcare systems

Based on reviews from: ClearView Diagnostics Inc. official website, Healthcare IT news articles (general CAD discussions), Medical imaging journals (general CAD discussions), Reddit (limited specific discussion), G2 (no specific reviews found), Capterra (no specific reviews found)

Last updated: 2026-07-17

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Press & Coverage

Predicase
ClearView cCAD (K161959) u2014 FDA 510(k) Clearance
ClearView cCAD, developed by Clearview Diagnostics, Inc., received Class II FDA 510(k) clearance on December 28, 2016, for lesion classification in ultrasound.
2016-12
FDA
K161959 - 510(k) Premarket Notification - FDA
This FDA document details the 510(k) Premarket Notification for ClearView cCAD, submitted by Clearview Diagnostics, Inc., indicating its clearance as a Class II device for image processing.
2016-12
IEEE SPMB
Decision Quality Support in Diagnostic Breast Ultrasound through Artificial Intelligence - IEEE SPMB
This paper explores the ClearView cCAD algorithms' ability to enhance diagnostic quality in breast lesion analysis via automated reporting of lesion parameters, and its potential as a decision support system.
unknown
PMC - NIH
Updates in Artificial Intelligence for Breast Imaging - PMC - NIH
ClearView cCAD is listed as an FDA-approved application for ultrasound lesion classification, cleared on December 28, 2016, within a review of AI applications for breast imaging.
2021-12
PMC - NIH
Computational healthcare: Present and future perspectives (Review) - PMC
ClearView cCAD by ClearView Diagnostics Inc. is cited as an FDA-approved AI-based application for diagnosis in oncology from 2016.
2021-12
MDPI
Towards Clinical Application of Artificial Intelligence in Ultrasound Imaging - MDPI
ClearView cCAD is included in a list of FDA-approved AI-powered medical devices for ultrasound imaging, specifically for automatically classifying breast ultrasound images with BI-RADS categories using machine learning.
2021-06
FDA
Koios Medical, Inc. July 3, 2019 Mr. Lev Barinov VP of Clinical Excellence and Applied Research 500 7th Avenue, 8th Floor N - accessdata.fda.gov
This FDA document references ClearView cCAD (K161959) as a predicate device for Koios DS for Breast, noting its capability to assess shape and orientation for user-selected ROIs in breast ultrasound.
2019-07
PMC - NIH
Clinical Artificial Intelligence Applications: Breast Imaging - PMC
ClearView cCAD from ClearView Diagnostics Inc. is listed as an FDA-cleared AI system for ultrasound diagnosis in breast imaging, cleared on December 28, 2016.
2022-05

Videos

Product demos, reviews, and walkthroughs for ClearView cCAD.

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Frequently Asked Questions

ClearView cCAD, now known as Koiosu2122 DS, is an AI-powered software designed to assist physicians in analyzing breast ultrasound images. It leverages machine learning algorithms and multivariate pattern recognition to classify characteristics of user-selected regions of interest (ROIs), aiming to improve diagnostic accuracy and potentially reduce unnecessary biopsies.
ClearView cCAD (Koiosu2122 DS) received 510(k) clearance from the FDA in January 2017, signifying it has been deemed substantially equivalent to a legally marketed predicate device. This clearance indicates its compliance with FDA regulations for medical devices in the United States.
While ClearView cCAD assists in analysis, patient management decisions should not be made solely based on its results. The software classifies user-selected ROIs and does not automatically segment lesions, though its performance is comparable to a radiologist without this additional step.
ClearView cCAD is described as a platform-agnostic web service capable of querying and accepting DICOM-compliant digital medical files from ultrasound devices, other DICOM sources, or PACS servers. This design facilitates its integration into existing imaging workflows within a healthcare setting.
Yes, there are other AI-powered computer-aided diagnosis (CAD) systems for breast ultrasound interpretation, such as the S-Detect system. While specific comparative performance details against all alternatives are not readily available, ClearView cCAD has demonstrated high accuracy in identifying breast cancers and reducing benign breast lesion biopsies in studies.
Specific pricing models for ClearView cCAD (Koiosu2122 DS) are not publicly detailed in the provided search results. Generally, pricing for medical AI software can involve licensing fees, per-study charges, or subscription models, and typically requires direct inquiry with the vendor for detailed information. Hospital and clinic adoption considerations often include integration costs, training, and long-term support.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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