Cirrus Resting State fMRI Software
K251009Sora Neuroscience, Inc. · cleared 2025-06-06 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Cirrus Resting State fMRI Software (Cirrus) is software as a medical device (SaMD) that performs image processing, resting state functional magnetic resonance imaging analysis, and output generation.”
source quote (p.5)
“Software components making up Cirrus include (i) a suite of fMRI preprocessing tools; (ii) a voxel-wise resting state fMRI correlation map generator, (iii) a nonadaptive machine-learning based resting state network (RSN) membership scoring algorithm; and (iv) an RSN map output generator.”
source quote (p.5)
“Software components making up Cirrus include (i) a suite of fMRI preprocessing tools; (ii) a voxel-wise resting state fMRI correlation map generator, (iii) a nonadaptive machine-learning based resting state network (RSN) membership scoring algorithm; and (iv) an RSN map output generator.”
source quote (p.7)
“Software unit testing, verification testing, clinical performance validation testing, host platform testing, and cybersecurity penetration testing have been conducted upon Cirrus according to defined protocols. The design and development of Cirrus complies with direction found in ISO 13485:2016 (Medical device quality management requirements and systems), IEC-62304:2006 + A1:2015 (Software life cycle processes), ANSI/AAMI/ISO 14971:2019 (Risk management for medical devices), AAMI TIR57:2016/R2019 (Medical device security / risk management), and NEMA PS 3.1-3.20 2024e (DICOM set).”
Validation studies (3)
Retrospective clinical
n=692 patients · 2 site(s)
endpoints: spatial correlation with corresponding SMN maps; spatial correlation with corresponding LAN maps
standards: ISO 13485:2016, IEC-62304:2006 + A1:2015, ANSI/AAMI/ISO 14971:2019, AAMI TIR57:2016/R2019, NEMA PS 3.1-3.20 2024e
Retrospective clinical
n=26 patients
endpoints: area under the ROC curve
standards: ISO 13485:2016, IEC-62304:2006 + A1:2015, ANSI/AAMI/ISO 14971:2019, AAMI TIR57:2016/R2019, NEMA PS 3.1-3.20 2024e
Bench
n=8 patients · 8 site(s)
endpoints: within-subject similarity across scanner types; cross-subject similarity
standards: ISO 13485:2016, IEC-62304:2006 + A1:2015, ANSI/AAMI/ISO 14971:2019, AAMI TIR57:2016/R2019, NEMA PS 3.1-3.20 2024e
Reported performance (1 observation)
source quote (p.8)
“Cirrus vision maps had a mean area under the ROC curve of 0.84, demonstrating comparability to task-activated vision maps.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).