# K152602: Olea Sphere V3.0

- Pathway: 510(k) (Traditional)
- Applicant: Olea Medical
- Decided: Mar 3, 2016 after 174 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: 11 generations back to K971684 (1997). 47 ancestors in all.
17 later devices descend from it; 11 cite it directly.
3 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132095: Olea Sphere, Olea Medical (2013) Summary page 6.
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio, Siemens Medi Cal Solutions, Inc. (2012) Summary page 6.
- K130749: Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular, Siemens Medical Solutions USA, Inc. (2013) Summary page 6.
- K141977: Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel, Siemens Medical Solutions USA, Inc. (2014) Summary page 7.

## Most influential descendants
- 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
- K182716: Brain Perfusion (BP) application (2019), 1 descendant of its own

## Indications for use
Olea Sphere V3.0 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, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. Olea Sphere V3.0 provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a Diffusion Weighted MRI (DW]I) / Fiber Tracking Module and a Dynamic Analysis Module (e.g. dynamic exogenous or endogenous 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 while repeating acquisitions (e.g. over time with or without variable acquisition parameters) 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. Arterial Spin Labeling (ASL) Module - the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion. Relaxometry Module — the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate. Metabolic Module — the calculation of parameters related to the fat fraction based on a MR technique using opposed-phase imaging.

Source page: https://510kreport.com/device/K152602
Methodology: https://510kreport.com/methodology