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 Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software
Primary Device IDEOLEBREASTSCAPEV1P00
NIH Device Record Key03bc39af-2b2d-4afc-9abd-9b246640f315
Commercial Distribution StatusIn Commercial Distribution
Brand NameBREASTSCAPE
Version Model NumberV1.0
Company DUNS047358761
Company NameOlea Medical USA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEOLEBREASTSCAPEV1P00 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-22
Device Publish Date2021-09-14

Devices Manufactured by Olea Medical USA

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EOLEOLEASIAV1P00 - Olea S.I.A V1.02022-11-30 Olea S.I.A V1.0 is a medical image communications device that provides electronic transfer of medical image data between medical
EOLEFMRIV1P00 - FUNCTIONAL MR2022-09-30 Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software
EOLEBREASTSCAPEV1P00 - BREASTSCAPE2021-09-22breastscape 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 - BREASTSCAPE2021-09-22 breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software pack
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