AccessGUDID - DEVICE: Automation Platform (EOLEAUTOMATIONV1P01)

GUDID

Device Identifier (DI) Information

Brand Name: Automation Platform
Version or Model: 1.0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Olea Medical USA

Primary DI Number: EOLEAUTOMATIONV1P01
Issuing Agency: HIBCC
Commercial Distribution End Date: November 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 047358761 *Terms of Use

Device Description: The Automation Platform is a software product that transfers, stores, converts formats, and displays medical device image data. It does not modify the image data or modify the display of the image data. The Automation Platform reads images and interprets DICOM tags, analyzes pixels to identify body part and sequence type in order to categorize the images. The Automation Platform is not intended to be used for active patient monitoring nor primary image interpretation. The Automation Platform allows routing DICOM-compliant image data to and from automated post processing applications, but such processing applications are not a part of the platform itself. Automation Platform allows post processing applications to provide a notification or a flag intended to inform the user.

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
LMD	System, Digital Image Communications, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: ebd8b385-43a4-43f1-b37d-a2b015d81190
Public Version Date: October 18, 2023
Public Version Number: 3
DI Record Publish Date: November 25, 2019