Koios DS Breast is software that assists trained interpreting physicians in analyzing breast ultrasound images. The core AI engine characterizes image features to generate output that aligns to BI-RADSĀ® ATLAS* categories (Benign, Probably Benign, Suspicious, Probably Malignant). The engine also classifies on the basis of shape and orientation. The software exports results to third-party reporting software. Time to generate and present results for two analyzed ROIs is <= 2 seconds.
Product specifications Information source: Vendor
Last updated: March 17, 2022
Product name Koios DS Breast
Company Koios Medical, Inc.
Subspeciality Breast
Modality Ultrasound
Disease targeted Breast cancer
Key-features BI-RADS categorization, lesion classification, confidence level indicator, smart calipers, one-click diagnosis
Suggested use During: perception aid (prompting all abnormalities/results/heatmaps), interactive decision support (shows abnormalities/results only on demand), report suggestion
Data characteristics
Population Women with lesions suspicious for breast cancer - Not for Pediatric use
Input Ultrasound images
Input format DICOM images
Output BI-RADS Categorization and Classifiers, Shape, Orientation, Confidence Level Indicator, Position, Size
Output format Web application https, DICOM C-Store, MagView, Nuance, etc.
Integration Integration in standard reading environment (PACS), Integration RIS (Radiological Information System), Integration via AI marketplace or distribution platform, Integrated on ultrasound scanner
Deployment Locally virtualized (virtual machine, docker), Cloud-based, On scanner
Trigger for analysis On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time < 3 sec
Certified, Class IIa , MDD
510(k) cleared, Class II
Market presence
On market since 03-2018
Distribution channels Nuance, MagView, 3M MModal, PenRad, GE Healthcare, all major PACS
Countries present (clinical, non-research use) 20+
Paying clinical customers (institutes) 28+
Research/test users (institutes) 13+
Pricing model Subscription, Activation Fee
Based on Number of users, Number of analyses
Peer reviewed papers on performance

  • Impact of Data Presentation on Physician Performance Utilizing Artificial Intelligence-Based Computer-Aided Diagnosis and Decision Support Systems (read)

  • Should we ignore, follow, or biopsy? Impact of artificial intelligence decision support on breast ultrasound lesion assessment (read)

Non-peer reviewed papers on performance

  • RSNA 2020 - Mango - Decreasing Benign Breast Ultrasound Biopsies: Prospective Use of AI Decision Support (read)

  • SIIM2021.org - Barinov - Improving the Efficacy of TI-RADS Through Artificial Intelligence (read)

  • SBI ACR Breast Imaging Symposium 2020 - Cavallo - AI Analysis of Ultrasound Images Could Decrease Benign Breast Biopsies (read)

Other relevant papers