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; AI-reconstructed

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)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

standards: IEC 62304:2006

Reported performance (6 observations)

diceas written: “T1 Left Ventricle Dice Overlap”84

source quote (p.7)

“Left Ventricle 84”

diceas written: “T1 Right Ventricle Dice Overlap”82

source quote (p.7)

“Right Ventricle 82”

diceas written: “T1 Whole Brain Dice Overlap”95

source quote (p.7)

“Whole Brain 95”

diceas written: “T2 Left Ventricle Dice Overlap”81

source quote (p.7)

“Left Ventricle 81”

diceas written: “T2 Right Ventricle Dice Overlap”79

source quote (p.7)

“Right Ventricle 79”

diceas written: “T2 Whole Brain Dice Overlap”96

source quote (p.7)

“Whole Brain 96”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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). 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).