# K223532: Olea S.I.A. Neurovascular V1.0

- Pathway: 510(k) (Traditional)
- Applicant: Olea Medical
- Decided: Jun 6, 2023 after 195 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.
1 later device descends from it; 1 cites it directly.
3 of 50 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.

## Most influential descendants
- K243680: Neurovascular Insight V1.0 (2025), 0 descendants of its own

## Indications for use
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 device does not alter the original image information and is not intended to be used as a diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes. 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/K223532
Methodology: https://510kreport.com/methodology