DEVICE: MR DWI/FLAIR Measurement (EOLEMRDFMV1P00)
Device Identifier (DI) Information
MR DWI/FLAIR Measurement
V1.0
In Commercial Distribution
Olea Medical USA
V1.0
In Commercial Distribution
Olea Medical USA
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LLZ | System, Image Processing, Radiological |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K230552 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7b5f2646-9910-4713-8278-e49bfd55a03e
October 18, 2023
2
May 04, 2023
October 18, 2023
2
May 04, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+33442712420
contact@olea-medical.com
contact@olea-medical.com