breastscape v1.0
Olea Medicalbreastscape v1.0 is an advanced software tool used with Olea Sphere 3.0 to assist breast imaging physicians and MRI technologists in analyzing breast MRI data. It provides visualization, semi-automatic lesion segmentation, kinetic curve analysis, and planning assistance for MR-guided breast biopsy procedures, helping clinicians detect and characterize breast lesions and plan interventions more effectively.
Intended Use
breastscape V1.0 is an optional image processing software application used on Olea Sphere 3.0, intended for use by breast imaging physicians and MRI technologists. It supports visualization, analysis, and reporting of breast MRI lesions, dynamic contrast evaluation, lesion measurements, and MR-guided breast intervention planning.
Technology
breastscape V1.0 is a PACS software module that operates within Olea Sphere 3.0 accessing MR image series in DICOM format. It comprises two modules: BreastApp for visualization, semi-automatic lesion segmentation, kinetic curve computation, parametric imaging, and reporting; and BreastLoc for assisting MR-guided breast interventional procedure planning.
Performance
Extensive validation was conducted including software verification, validation, risk assessment, and comparison with predicate devices MultiView V4.0.3.2 and Olea Sphere V3.0. Clinical and software testing showed breastscape V1.0 is as safe and effective as predicate devices for breast MRI lesion analysis and intervention planning.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/7/2021
2 months - 2
FDA Approval
8/2/2021
Other devices from Olea Medical
- MR DWI/FLAIR Measurement V1.02023 • 510K
- MR Diffusion Perfusion Mismatch V1.02023 • 510K
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