InVision Precision LVEF (LVEF)

K232331

InVision Medical Technology Corporation · cleared 2024-04-25 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“InVision Precision LVEF is a software as a medical device (SaMD)”

Algorithmmachine learning algorithm; Spatiotemporal Pooling

source quote (p.5)

“generates semi-automatic segmentations of the left ventricle using a machine learning algorithm to form the basis for the calculator of the LVEF output. Network Architecture Spatiotemporal Pooling”

Adaptive (vs locked)No

source quote (p.5)

“The user has the option to modify the semi-automatic segmentations suggested by the software. The EF calculation is updated in real-time with the user's modification of the segmentation. A cardiologist can adjust the annotations and the downstream measurement of LVEF prior to finalization.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: Root Mean Square Deviation below a set threshold; Dice score above a set threshold

Reported performance (2 observations)

diceas written: “Dice score for A4C segmentation”0.89

source quote (p.7)

“The Dice score for A4C segmentation was 0.89”

diceas written: “Dice score for A2C segmentation”0.9

source quote (p.7)

“and for A2C segmentation was 0.90”

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

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).