AccessGUDID - DEVICE: BREASTSCAPE (EOLEBREASTSCAPEV1P00)

GUDID

Device Identifier (DI) Information

Brand Name: BREASTSCAPE
Version or Model: V1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Olea Medical USA

Primary DI Number: EOLEBREASTSCAPEV1P00
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047358761 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41670	Radiological PACS software	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological
QIH	Automated Radiological Image Processing Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211431	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 03bc39af-2b2d-4afc-9abd-9b246640f315
Public Version Date: October 18, 2023
Public Version Number: 2
DI Record Publish Date: September 14, 2021