# K132095: Olea Sphere

- Pathway: 510(k) (Traditional)
- Applicant: Olea Medical
- Decided: Dec 26, 2013 after 171 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: 10 generations back to K896095 (1990). 11 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120196: Olea Sphere, Olea Medical (2012). Our OCR of the scanned summary read K120186, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Olea Sphere”. Summary page 3.

## Most influential descendants
- K152602: Olea Sphere V3.0 (2016), 17 descendants of its own
- K223532: Olea S.I.A. Neurovascular V1.0 (2023), 1 descendant of its own
- K211059: CereFlow™ V1.2 (2023), 1 descendant of its own
- K212565: CoverScan v1 (2022), 1 descendant of its own
- K203582: QUIBIM Precision Prostate (qp-Prostate) (2021), 1 descendant of its own

## Indications for use
Olea Sphere is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf” workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. Olea Sphere provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a Diffusion Weighted MRI (DWI1) / Fiber Tracking Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT), The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system. The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time where such techniques are useful or necessary. This functionality is referred to as: Perfusion Module — the calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Permeability Module — the calculation of parameters related to leakage of injected contrast material from intravascular to extracellular space.

Source page: https://510kreport.com/device/K132095
Methodology: https://510kreport.com/methodology