Breastscape

FDA UDI

Class II (US FDA UDI)

by Olea Medical USA

Identity

Trade Name: BREASTSCAPE FDA UDI
Generic Name: Radiological PACS software FDA UDI
Device Name: 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. FDA UDI
Model / Reference: V1.0 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: EOLEBREASTSCAPEV1P00 FDA UDI
510(k) Number: K211431 FDA UDI
FDA Product Code: LLZ FDA UDI
QIH FDA UDI
GMDN Term: Radiological PACS software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Radiological PACS software

Breastscape by Olea Medical USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological PACS software.

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IMAGEGRID RADIOLOGY VIEWER SYSTEM — Candelis, Inc. · Class II
EAGLESOFT — PATTERSON TECHNOLOGY CENTER · Class II
QuantX — Qlarity Imaging · Class II
interWORKS — Avreo, Inc. · Class I
NovaPACS — Novarad Corporation · Class II
OrthoNext™ Platform System Software — Orthofix, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Olea Medical USA

Sources (1)

FDA UDI 03bc39af-2b2d-4afc-9abd-9b246640f315 35 fields · synced May 30, 2026