# K230552: MR DWI/FLAIR Measurement V1.0

- Pathway: 510(k) (Traditional)
- Applicant: Olea Medical
- Decided: Apr 26, 2023 after 57 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K971684 (1997). 48 ancestors in all.
No later device cites it as a predicate yet.
3 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152602: Olea Sphere V3.0, Olea Medical (2016) Summary page 4.

## Indications for use
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. The device does not alter the original medical image. MR DWI/FLAIR Measurement V1.0 is not intended to be used as a standalone diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes. Patient management decisions should not solely be based on MR DWI/FLAIR Measurement V1.0 results. MR DWI/FLAIR Measurement V1.0 can be integrated and deployed through technical platforms, responsible for transferring, storing, converting formats, notifying of detected image variations and display of DICOM imaging data.

Source page: https://510kreport.com/device/K230552
Methodology: https://510kreport.com/methodology