# K251009: Cirrus Resting State fMRI Software

- Pathway: 510(k) (Traditional)
- Applicant: Sora Neuroscience, Inc.
- Decided: Jun 6, 2025 after 66 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 2 generations back to K081512 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222359: Quicktome Software Suite, Omniscient Neurotechnology Pty Ltd (O8t) (2023) Summary page 5.

## Indications for use
Cirrus Resting State fMRI Software (Cirrus) is a software solution that performs magnetic resonance image processing including the processing of blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) data, resting state fMRI analysis, and output generation. Cirrus generates task-analogous motor, language, and vision resting state fMRI correlation maps, in DICOM® format for visualization and analysis external to Cirrus. Cirrus maps have been found to vary in normal subjects tested by repeat MR acquisition under conditions where no functional mapping change was expected. Medical imaging processing systems intended for BOLD fMRI post-processing are adjunctive and not intended to replace direct functional mapping procedures. Typical users of Cirrus are medical professionals, including but not limited to surgeons, radiologists, and other clinicians.

Source page: https://510kreport.com/device/K251009
Methodology: https://510kreport.com/methodology