Viz HDS, Viz Volume Plus, Viz ICH+

K232363

Viz.ai, Inc. · cleared 2024-02-05 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Viz HDS is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm”
Algorithmartificial intelligence machine learning (AI/ML) algorithm, deep-learning algorithm
source quote (p.5)
“Viz HDS is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm to processes non-contrast head CT scans to outline intracranial hyperdensity areas, lateral ventricles (right and left), midline shift, and then quantify the volume of intracranial hyperdensity(ies), volume of lateral ventricles, lateral ventricle asymmetry ratio and distance of midline shift.Both the subject and predicate device use a deep-learning algorithm that analyzes NCCT images for identifying, labeling and quantifying volume of segmentable brain structures.”
Adaptive (vs locked)No
source quote (p.5)
“Viz HDS is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: MAE for hyperdensities total volume; MAE for right lateral ventricle volume; MAE for left lateral ventricle volume; MAE for midline shift distance; DICE score for hyperdenity(ies); DICE score for lateral ventricles

Reported performance (2 observations)

diceas written: “DICE score for hyperdenity(ies)”stated without valueCI greater than 70%
source quote (p.10)
“Additionally, DICE score was calculated to describe the degree of agreement between the measurements by the Viz HDS algorithm in comparison to the measurements that were obtained manually. The study demonstrated that the DICE score for hyperdenity(ies) and both lateral ventricles lower Cl bound was greater than 70%, which was aligned with the performance goal.”
diceas written: “DICE score for lateral ventricles”stated without valueCI greater than 70%
source quote (p.10)
“Additionally, DICE score was calculated to describe the degree of agreement between the measurements by the Viz HDS algorithm in comparison to the measurements that were obtained manually. The study demonstrated that the DICE score for hyperdenity(ies) and both lateral ventricles lower Cl bound was greater than 70%, which was aligned with the performance goal.”

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/K232363