Viz RV/LV

K221100

Viz.ai, Inc. · cleared 2022-08-29 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“The Viz RV/LV is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm to measure the maximal diameters of the right and left ventricles of the heart from a computed tomography pulmonary angiogram (CTPA) and report the ratio of those measurements.”

Algorithmlocked artificial intelligence machine learning (AI/ML) algorithm

source quote (p.4)

“The Viz RV/LV is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm to measure the maximal diameters of the right and left ventricles of the heart from a computed tomography pulmonary angiogram (CTPA) and report the ratio of those measurements.”

Adaptive (vs locked)No

source quote (p.4)

“The Viz RV/LV is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm to measure the maximal diameters of the right and left ventricles of the heart from a computed tomography pulmonary angiogram (CTPA) and report the ratio of those measurements.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

sample size not stated · 4 site(s)

endpoints: Mean absolute error (MAE); degree of agreement between ventricle diameters

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

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) K250354 (decision 2025-06-10) from Viz.ai, Inc. for a matching device line ("Viz Subdural+, Viz SUBDURAL PLUS") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250354
re_clearance
The FDA AI/ML device list shows a newer 510(k) K232363 (decision 2024-02-05) from Viz.ai, Inc. for a matching device line ("Viz HDS, Viz Volume Plus, Viz ICH+") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232363
re_clearance
The FDA AI/ML device list shows a newer 510(k) K223443 (decision 2023-03-17) from Viz. ai, Inc. for a matching device line ("Viz AAA") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K223443
re_clearance
The FDA AI/ML device list shows a newer 510(k) K223042 (decision 2022-10-21) from Viz.ai, Inc. for a matching device line ("Viz LVO ContaCT") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K223042

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).