olea-medical.comCT Perfusion V1.0
Olea Medical
OLEA MEDICAL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007675959 | 3007675959 | OLEA MEDICAL | 1 | N | 2026-01-01 | 93 Avenue du Sorbier, Zone Athelia IV La Ciotat Bouches-du-Rhone FR 13600 |
| 3007874106 | 3007874106 | Olea Medical Solutions Inc. | 1 | Y | 2026-01-01 | 1955 Massachusetts Avenue Suite 12 & 14 Cambridge MA US 02140 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| EOLEBREASTSCAPEV1P00 | BREASTSCAPE - 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. | +33442712420 | contact@olea-medical.com |
| EOLEFMRIV1P00 | FUNCTIONAL MR - Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package. It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers. Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps. Functional MR V1.0 can also be used to provide reproducible measurements of derived maps. These measurements include thresholds modification and ROI analysis. Functional MR V1.0 may also be used as an image viewer of multi-modality digital images, including BOLD and DTI images. | +33442712420 | contact@olea-medical.com |
| EOLEMRDPMV1P00 | MR Diffusion Perfusion Mismatch - MR Diffusion Perfusion Mismatch V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software allowing computation of parametric maps from (1) MR Diffusion-weighted imaging (DWI) and (2) MR Perfusion-weighted imaging (PWI) and extraction of volumes of interest based on numerical thresholds applied to the aforementioned maps. Computation of mismatch between extracted volumes is automatically provided. The device is intended to assist trained radiologists and surgeons in the imaging assessment workflow by extraction and communication of metrics from MR Diffusion-weighted imaging (DWI) and MR Perfusion-weighted imaging (PWI). The results of MR Diffusion Perfusion Mismatch V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment. MR Diffusion Perfusion Mismatch V1.0 can be integrated and deployed through technical platforms. | +33442712420 | contact@olea-medical.com |
| EOLEOLEASPHEREV2P31 | OLEA SPHERE - Olea Sphere V2.3 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. | +1 617 354 0721 | contact@olea-medical.com |
| EOLEOLEASPHEREV3P01 | OLEA SPHERE - Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. | +1 617 354 0721 | contact@olea-medical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 100786 | 1023919997 | K243681 | Neuro Insight V1.0 | LLZ | 2025-07-23 |
| 100786 | 1943675985 | K243680 | Neurovascular Insight V1.0 | LLZ | 2025-08-25 |
| 100786 | 1904932435 | K230552 | MR DWI/FLAIR Measurement V1.0 | LLZ | 2023-04-26 |
| 100786 | 2045997097 | K223502 | MR Diffusion Perfusion Mismatch V1.0 | LLZ | 2023-01-13 |
| 100786 | 1361442600 | K223091 | CT Perfusion V1.0 | LLZ | 2023-06-09 |
| 100786 | 1086324858 | K221426 | Functional MR V1.0 | LLZ | 2022-07-06 |
| 100786 | 1581607463 | K211431 | breastscape v1.0 | QIH | 2021-08-02 |
| 100786 | 1259021974 | K152602 | Olea Sphere V3.0 | LLZ | 2016-03-03 |
| 100786 | 1970785050 |
Product Codes Associated With Registrations#
PMN#
Olea S.I.A. Neurovascular V1.0
Olea Medical
MR DWI/FLAIR Measurement V1.0
Olea Medical
MR Diffusion Perfusion Mismatch V1.0
Olea Medical
Functional MR V1.0
Olea Medical SAS
Breastscape V1.0
Olea Medical
Olea Sphere V3.0
OLEA MEDICAL
OLEA SPHERE
OLEA MEDICAL
OLEA SPHERE
OLEA MEDICAL
PERFSCAPE V2.0
OLEA MEDICAL
PERFSCAPE
OLEA MEDICAL
NEUROSCAPE
OLEA MEDICAL
GUDID#
OLEA SPHERE - Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
2016-09-22
OLEA SPHERE - Olea Sphere V2.3 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
2017-05-12
Automation Platform - 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.
2019-11-25
BREASTSCAPE - 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.
2021-09-14
FUNCTIONAL MR - Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package. It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers. Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps. Functional MR V1.0 can also be used to provide reproducible measurements of derived maps. These measurements include thresholds modification and ROI analysis. Functional MR V1.0 may also be used as an image viewer of multi-modality digital images, including BOLD and DTI images.
2022-09-22
Olea S.I.A V1.0 - Olea S.I.A V1.0 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Olea S.I.A V1.0 stores, converts formats and displays medical device data. Olea S.I.A V1.0 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. Olea S.I.A V1.0 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Olea S.I.A V1.0 reads DICOM tags and pixel data to label images. Olea S.I.A V1.0 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs. Olea S.I.A V1.0 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan. Olea S.I.A V1.0 is intended to be used by trained professionals. Olea S.I.A V1.0 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.
2022-11-22
Automation Platform V1.5 - 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.
2022-11-22
MR Diffusion Perfusion Mismatch - MR Diffusion Perfusion Mismatch V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software allowing computation of parametric maps from (1) MR Diffusion-weighted imaging (DWI) and (2) MR Perfusion-weighted imaging (PWI) and extraction of volumes of interest based on numerical thresholds applied to the aforementioned maps. Computation of mismatch between extracted volumes is automatically provided. The device is intended to assist trained radiologists and surgeons in the imaging assessment workflow by extraction and communication of metrics from MR Diffusion-weighted imaging (DWI) and MR Perfusion-weighted imaging (PWI). The results of MR Diffusion Perfusion Mismatch V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment. MR Diffusion Perfusion Mismatch V1.0 can be integrated and deployed through technical platforms.
2023-03-08
MR DWI/FLAIR Measurement - MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of: (1) MR Diffusion-weighted imaging (DWI) (2) MR FLAIR images. The device is intended to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians in the imaging assessment workflow: • computation of the map relative to the water diffusion, i.e., ADC map; • extraction and communication of metrics derived from the above map, i.e., hypointense area on ADC, and FLAIR series as well as ratios with contralateral information on FLAIR images. The results of MR DWI/FLAIR Measurement V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment. Trained professionals are responsible for viewing the full set of native images per the standard of care. MR DWI/FLAIR Measurement V1.0 can be integrated and deployed through technical platforms.
2023-05-04
Olea S.I.A. Neurovascular - Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical technical integration platform Olea S.I.A. V1.0 and is designed to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians. Olea S.I.A. Neurovascular V1.0 is intended to: • display MR and CT series and outputs provided by compatible docker applications processing, through the technical integration platform, • allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display can be updated with the reprocessed outputs. The information displayed is intended to be used in conjunction with other patient information and based on professional judgment, to assist the clinician in the medical imaging assessment. It is not intended to be used in lieu of the standard care imaging. Trained professionals are responsible for viewing the full set of native images per the standard of care.
2023-07-31
CT Perfusion - CT Perfusion V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software allowing computation of parametric maps from CT Perfusion data and extraction of volumes of interest based on numerical thresholds applied to the aforementioned maps. Computation of mismatch between extracted volumes is automatically provided. The device is intended to be used by trained professionals with medical imaging education including but not limited to, physicians and medical technicians in the imaging assessment workflow by extraction and communication of metrics from CT Perfusion dataset. The results of CT Perfusion V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment. Trained professionals are responsible for viewing the full set of native images per the standard of care. CT Perfusion V1.0 can be integrated and deployed through technical platforms.
2023-07-31
Neurovascular Insight - Neurovascular Insight V1.0 is an optional user interface for use on a compatible technical integration environment and designed to be used by trained professionals with medical imaging education including, but not limited to, physicians. Neurovascular Insight V1.0 is intended to: • Display and, if necessary, export neurological DICOM series and outputs provided by compatible processing docker applications, through the technical integration environment. • Allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided by the technical integration environment as inputs to the docker application to reprocess the outputs. When available, Neurovascular Insight V1.0 display can be updated with the reprocessed outputs. • If requested by an application, allow the user to confirm information before displaying associated outputs and export them.
2026-04-13
Neuro Insight - Neuro Insight V1.0 is an image processing solution. It is intended to assist appropriately trained medical professionals in their analysis workflow on neurological MRI images. Neuro Insight V1.0 is composed of two subsets, including an image processing application package (NeuroPro) and an optional user interface (Neuro Synchronizer).
2026-04-13