Lunit INSIGHT DBT

Key Features

  • 3d slice(s) selection showing the suspicious lesion(s)
  • Abnormality score
  • Breast cancer detection

General Information

Product name

Lunit INSIGHT DBT

Company

Subspeciality

Breast

Modality

Mammography

Disease targeted

Breast cancer

Main task

Not specified

Technical Specifications

Population

Female aged 19 years or older; symptomatic or screening population.

Patient population age

Not specified

Input

3D Digital Breast Tomosynthesis

Input format

DICOM

Output

Localization (color map, grayscale map, combined map, single color map), abnormality score for each lesion/side, binary assessment of abnormality, worklist order.

Output format

DICOM GSPS(Grayscale Softcopy Presentation State), DICOM Secondary Capture, DICOM SR (Structured Report), HL7

Integration

Integration CIS (Clinical Information System), Integration in standard reading environment (PACS), Integration RIS (Radiological Information System), Integration via AI marketplace or distribution platform, Stand-alone third party application, Stand-alone webbased

Deployment

Cloud-based, Locally on dedicated hardware, 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

1 - 10 minutes

Regulatory Information

CE Certification

Pathway:

MDR

Class:

Class IIa

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

03-2023

AI Platforms

Blackford Analysis, Deepc, Sectra

Resellers

Not specified

Countries present

Not specified

Paying clinical customers

Not specified

Research/test users

Not specified

Pricing Information

Pricing model

Not specified

Based on

Not specified

Evidence & Research

Peer-Reviewed Papers

Peer-Reviewed

View

Impact of AI for Digital Breast Tomosynthesis on Breast Cancer Detection and Interpretation Time

Source: vendor | First published: May 2, 2024 | Last updated: Jul 9, 2025