Automation Platform V1.5

GUDID EOLEAUTOMATIONV1P50

Automation Platform V1.5 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Automation Platform V1.5 stores, converts formats and displays medical device data. Automation Platform V1.5 allows the integration of separately registered or cleared processing applications owned by Olea Medical or third parties. These applications are not part of the platform itself. Automation Platform V1.5 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Automation Platform V1.5 reads DICOM tags and pixel data to label images. Automation Platform V1.5 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs. Automation Platform V1.5 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan. Automation Platform V1.5 is intended to be used by trained professionals. Automation Platform V1.5 is not intended for primary diagnosis, detailed treatment planning or treatment of patients and shall not be used to take decisions with diagnosis or therapeutic purposes.

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 IDEOLEAUTOMATIONV1P50
NIH Device Record Keybd061b57-c3e7-4903-a7f7-8fa19c602e53
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutomation Platform V1.5
Version Model Number1.5
Company DUNS047358761
Company NameOlea Medical USA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEOLEAUTOMATIONV1P50 [Primary]

FDA Product Code

LMDSystem, Digital Image Communications, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-30
Device Publish Date2022-11-22

Devices Manufactured by Olea Medical USA

EOLECTPERFUSIONV1P00 - CT Perfusion2023-08-08 CT Perfusion V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software al
EOLENEUROVASV1P00 - Olea S.I.A. Neurovascular2023-08-08 Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical technical integration platform Olea S.I
EOLEMRDFMV1P00 - MR DWI/FLAIR Measurement2023-05-12 MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of: (1) MR Diffusion-weighted
EOLEMRDPMV1P00 - MR Diffusion Perfusion Mismatch2023-03-16 MR Diffusion Perfusion Mismatch V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image pro
EOLEAUTOMATIONV1P50 - Automation Platform V1.52022-11-30Automation Platform V1.5 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Automation Platform V1.5 stores, converts formats and displays medical device data. Automation Platform V1.5 allows the integration of separately registered or cleared processing applications owned by Olea Medical or third parties. These applications are not part of the platform itself. Automation Platform V1.5 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Automation Platform V1.5 reads DICOM tags and pixel data to label images. Automation Platform V1.5 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs. Automation Platform V1.5 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan. Automation Platform V1.5 is intended to be used by trained professionals. Automation Platform V1.5 is not intended for primary diagnosis, detailed treatment planning or treatment of patients and shall not be used to take decisions with diagnosis or therapeutic purposes.
EOLEAUTOMATIONV1P50 - Automation Platform V1.52022-11-30 Automation Platform V1.5 is a medical image communications device that provides electronic transfer of medical image data betwee
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 - BREASTSCAPE2021-09-22 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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