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.”
Algorithmartificial 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...”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

sample size not stated · 4 site(s)

endpoints: MAE (Mean absolute error) was less than 7.2 mm between the algorithm and the established ground truth

Retrospective clinical

sample size not stated

endpoints: degree of agreement between the ventricle diameters measured by the RV/LV algorithm in comparison to the measurements that were obtained manually

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
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
4
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); 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/K221100