Rapid RV/LV

K223396

iSchema View Inc. · cleared 2023-02-01 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“The Rapid RV/LV software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements for adults. Rapid RV/LV analyzes cases using machine learning algorithms to identify locations and measurements of the ventricles. The Rapid RV/LV device provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.”

Algorithmmachine learning algorithms

source quote (p.3)

“Rapid RV/LV analyzes cases using machine learning algorithms to identify locations and measurements of the ventricles.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=516 cases

Standalone

n=124 cases

endpoints: average slope; average intercept; Bland-Altman bias; Mean Absolute Error (MAE)

standards: EN ISO 14971:2019 (R2021), IEC 62304:2006 (R2015), IEC 62366:2015 (R2020), NEMA PS 3.1 - 3.20

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) K233582 (decision 2024-04-22) from iSchema View Inc. for a matching device line ("Rapid") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233582

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).