BrainInsight

K223268

Hyperfine, 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. The BrainInsight processing architecture includes a proprietary automated internal pipeline based on machine learning tools.”
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: discrepancy; Dice coefficient; volume differences

standards: IEC 62304:2006

Reported performance (10 observations)

diceas written: “Left Ventricle Dice Overlap (Device) T1”85
source quote (p.8)
“Left Ventricle 85”
diceas written: “Right Ventricle Dice Overlap (Device) T1”83
source quote (p.8)
“Right Ventricle 83”
diceas written: “Whole Brain Dice Overlap (Device) T1”95
source quote (p.8)
“Whole Brain 95”
diceas written: “Left Ventricle Dice Overlap (Device) T2”84
source quote (p.8)
“Left Ventricle 84”
diceas written: “Right Ventricle Dice Overlap (Device) T2”82
source quote (p.8)
“Right Ventricle 82”
diceas written: “Whole Brain Dice Overlap (Device) T2”96
source quote (p.8)
“Whole Brain 96”
diceas written: “Left Ventricle Dice Overlap (Device) T2-Fast”86
source quote (p.8)
“Left Ventricle 86”
diceas written: “Right Ventricle Dice Overlap (Device) T2-Fast”86
source quote (p.8)
“Right Ventricle 86”
diceas written: “Left Ventricle Dice Overlap (Device) FLAIR”89
source quote (p.8)
“Left Ventricle 89”
diceas written: “Right Ventricle Dice Overlap (Device) FLAIR”88
source quote (p.8)
“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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K223268