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Key Features

  • AI independent risk assessment
  • Alignment to diagnostic classification systems
  • Auto-population of lesion/nodule descriptors
  • Lesion/nodule classification
  • Lesion/nodule segmentation

General Information

Product name

Koios DS

Subspeciality

Breast, Thyroid

Modality

Ultrasound

Disease targeted

Breast cancer, thyroid cancer

Main task

Not specified

Technical Specifications

Population

Adult (>= 22 years) female patients with soft tissue breast lesions and/or adult (>= 22 years) patients with thyroid nodules suspicious for cancer.

Patient population age

Not specified

Input

2 orthogonal still ultrasound views of either breast lesions or thyroid nodules

Input format

DICOM

Output

BI-RADS/TI-RADS Categorization and Classifiers, Shape, Orientation, Confidence Level Indicator, Position, Size

Output format

DICOM Client such as a scanner, DICOM Secondary Capture and/or DICOM Structured Report, Selected pacs integrations

Integration

Integration CIS (Clinical Information System), Integration in standard reading environment (PACS), Stand-alone third party application, Stand-alone webbased

Deployment

Locally virtualized (virtual machine, Docker)

Trigger for analysis

Automatically, Etc., Image upload, On demand, Right after the image acquisition, Triggered by a user through e.g. a button click

Processing time

< 3 sec

Regulatory Information

CE Certification

Pathway:

MDR

Class:

Class IIb

Verified by Health AI Register
FDA Certification

Pathway:

510(k) cleared

Class:

Class II

Verified by Health AI Register

Other certifications

Not specified

Market Presence

On market since

12-2021

AI Platforms

Alma Health Platform, GE Healthcare

Resellers

Amplify SDK, RMS Medical Devices

Countries present

25

Paying clinical customers

>80

Research/test users

>50

Pricing Information

Pricing model

Subscription

Based on

Number of analyses, Number of users

Evidence & Research

Peer-Reviewed Papers

Peer-Reviewed

View

Impact of an artificial intelligence decision support system among radiologists with different levels of experience in breast ultrasound: A prospective study in a tertiary center

Peer-Reviewed

View

Investigation of artificial intelligence–based clinical decision support system’s performance in reducing the fine needle aspiration rate of thyroid nodules: A pilot study

Peer-Reviewed

View

Artificial Intelligence in Diagnostic Breast Ultrasound: A Comparative Analysis of Decision Support Among Radiologists With Various Levels of Expertise

Peer-Reviewed

View

Avoidable biopsies? Validating artificial intelligence–based decision support software in indeterminate thyroid nodules

Peer-Reviewed

View

Assessment of the Diagnostic Performance of a Commercially Available Artificial Intelligence Algorithm for Risk Stratification of Thyroid Nodules on Ultrasound

Peer-Reviewed

View

Improving the Efficacy of ACR TI-RADS Through Deep Learning-Based Descriptor Augmentation

Peer-Reviewed

View

A role for breast ultrasound Artificial Intelligence decision support in the evaluation of small invasive lobular carcinomas

Peer-Reviewed

View

Toward AI-supported US Triage of Women with Palpable Breast Lumps in a Low-Resource Setting

Peer-Reviewed

View

Can an Artificial Intelligence Decision Aid Decrease False-Positive Breast Biopsies?

Peer-Reviewed

View

Impact of Original and Artificially Improved Artificial Intelligence–based Computer-aided Diagnosis on Breast US Interpretation

Peer-Reviewed

View

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

Peer-Reviewed

View

Should We Ignore, Follow, or Biopsy? Impact of Artificial Intelligence Decision Support on Breast Ultrasound Lesion Assessment

Technical Papers

Technical

View

SIIM2018 - Artificial Intelligence in Breast Ultrasound: Moving from Standalone Performance to the Physician-system Interface

Technical

View

SPMB 2016 - Decision Quality Support in Diagnostic Breast Ultrasound through Artificial Intelligence

Technical

View

Artificial intelligence in low- And middle-income countries: Innovating global health radiology

Technical

View

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

Technical

View

SIIM 2021 - Barinov - Improving the Efficacy of TI-RADS Through Artificial Intelligence

Technical

View

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

Source: vendor | First published: Oct 24, 2023 | Last updated: Jul 9, 2025