# K243681: Neuro Insight V1.0

- Pathway: 510(k) (Traditional)
- Applicant: Olea Medical S.A.S.
- Decided: Jul 23, 2025 after 236 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 5.

## Indications for use
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). NeuroPro is an image processing application package that computes maps, extracts and communicates metrics which are to be used in the analysis of multiphase or monophase neurological MR images. NeuroPro can be integrated and deployed through technical integration environment, responsible for transferring, storing, converting formats and displaying of DICOM imaging data. Neuro Synchronizer is an optional dedicated interface allowing the viewing, manipulation, and comparison of neurological medical imaging and/or multiple time-points, including post-processing results provided by NeuroPro or any other results from compatible processing applications. Neuro Synchronizer is a medical image management application intended to enable the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration environment as inputs to the application to reprocess outputs. If necessary, Neuro Synchronizer provides the user with the option to validate the information. Neuro Synchronizer can be integrated in compatible technical integration environments. The device does not alter the original medical image. Neuro Insight V1.0 is not intended to be used as a standalone diagnostic device and should not be used as the sole basis for patient management decisions. The results of Neuro Insight V1.0 are intended to be used in conjunction with other patient information and based on professional judgment to assist with reading and interpretation of medical images. Users are responsible for viewing full images per the standard of care.

Source page: https://510kreport.com/device/K243681
Methodology: https://510kreport.com/methodology