# K243680: Neurovascular Insight V1.0

- Pathway: 510(k) (Traditional)
- Applicant: Olea Medical S.A.S.
- Decided: Aug 25, 2025 after 269 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: 13 generations back to K971684 (1997). 49 ancestors in all.
No later device cites it as a predicate yet.
3 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223532: Olea S.I.A. Neurovascular V1.0, Olea Medical (2023) Summary page 5.

## Indications for use
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. The device does not alter the original image information and is not intended to be used as a diagnostic device. The outputs of each compatible application must be interpreted by the predefined intended users, as specified in the application's own labeling. Moreover, 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.

Source page: https://510kreport.com/device/K243680
Methodology: https://510kreport.com/methodology