BrainInsight

K220815

Hyperfine, Inc. · cleared 2022-07-19 · 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 of MR images from patients ages 18 years or older.”
Algorithmproprietary automated internal pipeline based on machine learning tools; machine learning models
source quote (p.4)
“The BrainInsight processing architecture includes a proprietary automated internal pipeline based on machine learning tools. The modified BrainInsight described in this submission includes changes to the machine learning models to allow for the processing Al-reconstructed low-field MR images.”
Adaptive (vs locked)No
source quote (p.6)
“Each model was trained using a training dataset to optimize parameters and a separate validation dataset to select the best set of parameters.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: non-inferiority testing; model discrepancy to annotators; mean absolute error for midline shift; mean Dice coefficient for lateral ventricles and whole brain

standards: IEC 62304:2006

Reported performance (12 observations)

diceas written: “Dice Overlap T1 Left Ventricle (Device)”84
source quote (p.7)
“Left Ventricle 84”
diceas written: “Dice Overlap T1 Left Ventricle (Annotator)”90
source quote (p.7)
“Left Ventricle 90”
diceas written: “Dice Overlap T1 Right Ventricle (Device)”82
source quote (p.7)
“Right Ventricle 82”
diceas written: “Dice Overlap T1 Right Ventricle (Annotator)”89
source quote (p.7)
“Right Ventricle 89”
diceas written: “Dice Overlap T1 Whole Brain (Device)”95
source quote (p.7)
“Whole Brain 95”
diceas written: “Dice Overlap T1 Whole Brain (Annotator)”97
source quote (p.7)
“Whole Brain 97”
diceas written: “Dice Overlap T2 Left Ventricle (Device)”81
source quote (p.7)
“Left Ventricle 81”
diceas written: “Dice Overlap T2 Left Ventricle (Annotator)”84
source quote (p.7)
“Left Ventricle 84”
diceas written: “Dice Overlap T2 Right Ventricle (Device)”79
source quote (p.7)
“Right Ventricle 79”
diceas written: “Dice Overlap T2 Right Ventricle (Annotator)”84
source quote (p.7)
“Right Ventricle 84”
diceas written: “Dice Overlap T2 Whole Brain (Device)”96
source quote (p.7)
“Whole Brain 96”
diceas written: “Dice Overlap T2 Whole Brain (Annotator)”97
source quote (p.7)
“Whole Brain 97”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K223268 (decision 2022-12-16) from Hyperfine, Inc. for a matching device line ("BrainInsight") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K223268

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/K220815