BrainInsight
K223268Hyperfine, Inc. · cleared 2022-12-16 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.4)
“BrainInsight is a fully automated MR imaging post-processing medical software that provides image alignment, whole brain segmentation, ventricle segmentation, and midline shift measurements of brain structures from a set MR images.”
Algorithmproprietary automated internal pipeline based on machine learning tools
source quote (p.4)
“The BrainInsight processing architecture includes a proprietary automated internal pipeline based on machine learning tools.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Retrospective clinical
sample size not stated
endpoints: Midline Shift Discrepancy; Lateral Ventricle Left Discrepancy; Lateral Ventricle Right Discrepancy; Dice Overlap; Volume Differences
standards: IEC 62304:2006
Reported performance (10 observations)
diceas written: “Dice Overlap (Device) - T1 Left Ventricle”85
source quote (p.8)
“Application Dice Overlap [%] T1 Device Left Ventricle 85”
diceas written: “Dice Overlap (Device) - T1 Right Ventricle”83
source quote (p.8)
“Application Dice Overlap [%] T1 Device Right Ventricle 83”
diceas written: “Dice Overlap (Device) - T1 Whole Brain”95
source quote (p.8)
“Application Dice Overlap [%] T1 Device Whole Brain 95”
diceas written: “Dice Overlap (Device) - T2 Left Ventricle”84
source quote (p.8)
“Application Dice Overlap [%] T2 Device Left Ventricle 84”
diceas written: “Dice Overlap (Device) - T2 Right Ventricle”82
source quote (p.8)
“Application Dice Overlap [%] T2 Device Right Ventricle 82”
diceas written: “Dice Overlap (Device) - T2 Whole Brain”96
source quote (p.8)
“Application Dice Overlap [%] T2 Device Whole Brain 96”
diceas written: “Dice Overlap (Device) - T2-Fast Left Ventricle”86
source quote (p.8)
“Application Dice Overlap [%] T2-Fast Device Left Ventricle 86”
diceas written: “Dice Overlap (Device) - T2-Fast Right Ventricle”86
source quote (p.8)
“Application Dice Overlap [%] T2-Fast Device Right Ventricle 86”
diceas written: “Dice Overlap (Device) - FLAIR Left Ventricle”89
source quote (p.8)
“Application Dice Overlap [%] FLAIR Device Left Ventricle 89”
diceas written: “Dice Overlap (Device) - FLAIR Right Ventricle”88
source quote (p.8)
“Application Dice Overlap [%] FLAIR Device Right Ventricle 88”
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
0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
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).