510(k) · Cleared
ClearedCirrus Resting State fMRI Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sora Neuroscience, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Jun 6, 2025 as substantially equivalent to K222359 (Omniscient Neurotechnology Pty Ltd (O8t), 2023) after a 66-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Jun 6, 2025
- Review
- 66 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K081512 (2008). No later device cites it as a predicate yet.
- Root · 2 generations backK081512 Stealthviz Advanced Planning Application with Stealthdti PackageMedtronic Navigation, Inc. · 2008
- 1 generation backK222359 Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (O8t) · 2023
- This deviceK251009 Cirrus Resting State fMRI SoftwareSora Neuroscience, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K081512 | Stealthviz Advanced Planning Application with Stealthdti Package | Medtronic Navigation, Inc. | 2008 | — |
| −1 | K222359 | Quicktome Software Suite | Omniscient Neurotechnology Pty Ltd (O8t) | 2023 | — |
| 0 (this device) | K251009 | Cirrus Resting State fMRI Software | Sora Neuroscience, Inc. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K222359 | Quicktome Software SuiteSummary page 5…92.2050) Regulatory Class: Class II Product Code: QIH Predicate Device Omniscient Neurotechnology Pty Ltd (o8t), Quicktome Software Suite, K222359. Device Description Cirrus Resting State fMRI Software (Cirrus) is software as a medical device (SaMD) that p… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 14.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K222359.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
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…
Read the full statement (121 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251009 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251009: Cirrus Resting State fMRI Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251009
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026