# K211431: breastscape v1.0

- Pathway: 510(k) (Traditional)
- Applicant: Olea Medical
- Decided: Aug 2, 2021 after 87 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K132316 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132316: Multiview, Hologic, Inc. (2013) Summary page 4.

## Indications for use
breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere 3.0 software package. It is intended to be used by trained 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 renderings). 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 includes the option to add annotations based on the fifth edition of the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS®) Breast Imaging Atlas. breastscape V1.0 may 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.

Source page: https://510kreport.com/device/K211431
Methodology: https://510kreport.com/methodology