BREASTSCAPE

GUDID EOLEBREASTSCAPEV1P00

breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software package cleared under K152602. It is intended to be used by trained breast imaging physicians and trained MRI technologists. breastscape V1.0 includes 2 software modules : - BreastApp supports the visualization, analysis, and reporting of lesions measurements and analysis. - BreastLoc to assist users in planning MR guided breast interventional procedures. Data and images are acquired through DICOM compliant imaging devices and modalities.

Olea Medical USA

Radiology PACS software

• Primary Device ID: EOLEBREASTSCAPEV1P00
• NIH Device Record Key: 03bc39af-2b2d-4afc-9abd-9b246640f315
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BREASTSCAPE
• Version Model Number: V1.0
• Company DUNS: 047358761
• Company Name: Olea Medical USA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com
• Phone: +33442712420
• Email: contact@olea-medical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EOLEBREASTSCAPEV1P00 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211431

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-22
• Device Publish Date: 2021-09-14

Devices Manufactured by Olea Medical USA

• EOLECTPERFUSIONV1P00 - CT Perfusion: 2023-08-08 CT Perfusion V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software al
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• EOLEMRDFMV1P00 - MR DWI/FLAIR Measurement: 2023-05-12 MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of: (1) MR Diffusion-weighted
• EOLEMRDPMV1P00 - MR Diffusion Perfusion Mismatch: 2023-03-16 MR Diffusion Perfusion Mismatch V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image pro
• EOLEAUTOMATIONV1P50 - Automation Platform V1.5: 2022-11-30 Automation Platform V1.5 is a medical image communications device that provides electronic transfer of medical image data betwee
• EOLEOLEASIAV1P00 - Olea S.I.A V1.0: 2022-11-30 Olea S.I.A V1.0 is a medical image communications device that provides electronic transfer of medical image data between medical
• EOLEFMRIV1P00 - FUNCTIONAL MR: 2022-09-30 Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software
• EOLEBREASTSCAPEV1P00 - BREASTSCAPE: 2021-09-22breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software package cleared under K152602. It is intended to be used by trained breast imaging physicians and trained MRI technologists. breastscape V1.0 includes 2 software modules : - BreastApp supports the visualization, analysis, and reporting of lesions measurements and analysis. - BreastLoc to assist users in planning MR guided breast interventional procedures. Data and images are acquired through DICOM compliant imaging devices and modalities.
• EOLEBREASTSCAPEV1P00 - BREASTSCAPE: 2021-09-22 breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software pack