breastscape V1.0

Primary DI

+EOLEBREASTCAPEV1P00

Basic UDI-DI Code

++EOLEBREASTSCAPEYM

Reference

SCPT001;SCPT002

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Olea Medical S.A.S.

breastscape® V1.0 is an optional medical viewing, analysis and processing, Picture Archiving Communications System (PACS) software application that is intended for use on Olea Sphere® 3.0 software package. breastscape® v1.0 includes a software module (BreastApp) designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) breast studies. It provides the hereinafter referred features: • Visualization (standard image viewing tools, MIPs and reformats) • Analysis (subtractions, kinetic curves and charts, parametric image maps, segmentation of volumes of interest, 2D and 3D distances and volumes measurements and 3D volume rendering) • Reporting of user-selected findings and assessment based on the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS®) Breast Imaging Atlas. breastscape® V1.0 includes a software module (BreastLoc) designed to provide interventional planning tools that assist users in planning MR guided breast interventional procedures. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. BreastApp and BreastLoc are complementary but can be used independently.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).