FDA.reportPublic FDA data

BREASTSCAPE

Primary DI
EOLEBREASTSCAPEV1P00
Brand
BREASTSCAPE
Company
Olea Medical USA
Model
V1.0
Device description
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.
Published
2021-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211431000breastscape v1.0Olea Medical2021-08-02QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EOLEBREASTSCAPEV1P00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33442712420contact@olea-medical.com

Regulatory Flags#

DUNS number
047358761
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EOLENEUROINSIGHTV1P00Neuro InsightV1.0AP-NI-MR or AP-NI-NP-MR or AP-NI-NS-MR2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightV1.0AP-NVI-CT or AP-NVI-MR2026-04-13
EOLECTPERFUSIONV1P00CT PerfusionV1.02023-07-31
EOLENEUROVASV1P00Olea S.I.A. NeurovascularV1.02023-07-31
EOLEMRDFMV1P00MR DWI/FLAIR MeasurementV1.02023-05-04
EOLEMRDPMV1P00MR Diffusion Perfusion MismatchV1.02023-03-08
EOLEAUTOMATIONV1P50Automation Platform V1.51.52022-11-22
EOLEOLEASIAV1P00Olea S.I.A V1.01.02022-11-22
EOLEFMRIV1P00FUNCTIONAL MRV1.02022-09-22
EOLEAUTOMATIONV1P01Automation Platform1.02019-11-25
EOLEOLEASPHEREV2P31OLEA SPHERE2.32017-05-12
EOLEOLEASPHEREV3P01OLEA SPHERE3.02016-09-22

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Primary DI, Brand, Company table
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