breastscape® v1.0

Olea Medical

Key Features

ACR classification
BI-RADS report
DCE and ADC quantification
Guidances for breast biopsy
Lesion follow-up
Lesion segmentation and volumetry

General Information

Product name

breastscape® v1.0

Company

Olea Medical

Subspeciality

Breast

Modality

Disease targeted

Breast cancer

Main task

Not specified

Technical Specifications

Population

all patients for Breast MRI analysis

Patient population age

Not specified

Input

All series from MRI examination including morphologic and functionnal sequences (DCE, DWI). Mammography and US modalities can be loaded for examination comparison.

Input format

DICOM

Output

BI-RADS Report, DCE, DWI computation maps, lesion segmentation overlay

Output format

DICOM (imaging), DICOM-PDF or secondary capture (report)

Integration

Integration in standard reading environment (PACS), Stand-alone third party application

Deployment

Locally on dedicated hardware, Locally virtualized (virtual machine, Docker)

Trigger for analysis

Etc., Image upload, On demand, Triggered by a user through e.g. a button click

Processing time

BreastLoc: <3 sec, BreastApp: 1 - 10 minutes

Regulatory Information

CE Certification

Pathway:

MDD

Class:

Class IIa

Verified by Health AI Register

breastscape® v1.0 is an optional image processing software application that is intended for use on Olea Sphere® v3.0 software package. It is intended to be used by breast imaging physicians and trained MRI technologists. breastscape® v1.0 includes a software module (BreastApp) that supports the visualization, analysis, and reporting of lesions measurements and analysis. breastscape® v1.0 supports the evaluation of dynamic MR data acquired during contrast administration and the calculation of parameters related to the uptake characteristics. breastscape® v1.0 performs other user selected processing functions (such as image subtraction, multiplanar and oblique reformats, 3D rendering). The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. breastscape® v1.0 can also be used to provide measurements of the segmented tissue volumes (volumes of interest) based on uptake characteristics. These measurements include volume measurement, distances of volumes of interest to anatomical landmarks, 3D longest diameter and 2D long and short axis. breastscape® v1.0 also includes the option to add annotations based on the ACR fifth edition 2013 BI-RADS® Breast Imaging Atlas. breastscape® v1.0 may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. breastscape® v1.0 is not intended for primary interpretation of digital mammography images. breastscape® v1.0 includes a software module (BreastLoc) to assists users in planning MR guided breast interventional procedures. Using information from MR images, regarding user-specified target lesion and fiducial location coordinates, the software gives calculation of the targeted region of interest (such as suspected lesion) depth. When interpreted by a skilled physician, breastscape® v1.0 provides information that may be used for screening, diagnosis, and interventional planning. Patient management decisions should not be based solely on the results of breastscape® v1.0.

FDA Certification

Pathway:

510(k) cleared

Class:

Class II

Verified by Health AI Register

Other certifications

Not specified

Market Presence

On market since

06-2018

AI Platforms

Not specified

Resellers

Not specified

Countries present

Not specified

Paying clinical customers

Not specified

Research/test users

Not specified

Pricing Information

Pricing model

Subscription

Based on

Number of users

Evidence & Research

No research papers or evidence available for this product.

Source: vendor | First published: Feb 7, 2022 | Last updated: Jul 9, 2025