# K221426: Functional MR V1.0

- Pathway: 510(k) (Traditional)
- Applicant: Olea Medical S.A.S.
- Decided: Jul 6, 2022 after 51 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K896095 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163324: nordicBrainEx, Nordicneurolab AS (2017) Summary page 4.

## Recalls of this device
- Aug 10, 2023 · Class II · Z-0122-2024: When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and as

## Indications for use
Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package. It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers. Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps. Functional MR V1.0 can also be used to provide reproducible measurements of derived maps. These measurements include thresholds modification and ROI analysis. Functional MR V1.0 may also be used as an image viewer of multi-modality digital images, including BOLD and DTI images. When interpreted by a skilled physician, Functional MR V1.0 provides information that may be used in a clinically useful context. Patient management decisions should not be based solely on the results of Functional MR V1.0.

Source page: https://510kreport.com/device/K221426
Methodology: https://510kreport.com/methodology