Viz LVO ContaCT

K223042

Viz.ai, Inc. · cleared 2022-10-21 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“Viz LVO uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation.”
Algorithmartificial intelligence machine learning (AI/ML) software algorithm
source quote (p.5)
“The Viz LVO Image Analysis Algorithm (LVO Detection Algorithm) is a locked, artificial intelligence machine learning (AI/ML) software algorithm that analyzes CTA images of the head for a suspected large vessel occlusion (LVO).”
Adaptive (vs locked)No
source quote (p.5)
“The Viz LVO Image Analysis Algorithm (LVO Detection Algorithm) is a locked, artificial intelligence machine learning (AI/ML) software algorithm that analyzes CTA images of the head for a suspected large vessel occlusion (LVO).”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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
0
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/K223042