Imbio RV/LV Software

K203256

Imbio, LLC · cleared 2021-03-09 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Imbio RV/LV Software is a Software and Medical Device (SaMD) intended to provide annotated images and a PDF report that will be read most typically at a PACS workstation.”

Algorithmartificial intelligence algorithm

source quote (p.3)

“RV/LV analyzes cases using an artificial intelligence algorithm to identify the location 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)

Bench

sample size not stated

Reader study (MRMC)

sample size not stated

endpoints: improvement of the agreement among general radiologist with the assistance of the RVLV output report; accuracy of RVLV diameter ratios compared to radiologist's measurement of the RVLV diameter ratio

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) K241847 (decision 2024-08-30) from Imbio, Inc for a matching device line ("Imbio PHA (4.0.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K241847

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).