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ProductsLunit INSIGHT DBT

Vendor source

Reviewed 11 May 2026

Completeness Strong (67%)

Lunit INSIGHT DBT

Lunit

Lunit INSIGHT DBT analyses 3D images from DBT to support diagnosis of breast cancer. Lunit INSIGHT DBT presents the 3D slice(s) on which a suspicious lesion(s) is best shown.

Supported by 2 papers

Lunit INSIGHT DBT
Lunit INSIGHT DBT
Lunit INSIGHT DBT thumbnail 1
Lunit INSIGHT DBT thumbnail 2

Key Features

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

General Information

Product name

Lunit INSIGHT DBT

Company

Modality

Mammography

Main task

Not specified

Subspeciality

Breast

Disease targeted

Breast cancer

Regulatory Information

CE Certification

Pathway:

MDR

Class:

Class IIa

Verified by Health AI Register

FDA Certification

Pathway:

510(k) cleared

Class:

Class II

FDA Number:

K231470

View FDA record

Verified by Health AI Register

Other certifications

Not specified

Evidence & Research

Technical Specifications

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, right after the image acquisition, On demand, triggered by a user through e.g. a button click, image upload

Processing time

1 - 10 minutes

Population

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

Market Presence

On market since

03-2023

AI Platforms

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

Source: Vendor | First published: May 2, 2024 | Last updated: May 11, 2026