Imbio PHA (4.0.0)

K241847

Imbio, Inc · cleared 2024-08-30 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Imbio PHA Software is a Software as a Medical Device (SaMD) intended to provide annotated DICOM-formatted images and a PDF report that will be read most typically at a PACS workstation.”

Algorithmartificial intelligence algorithm, deep-learning models

source quote (p.3)

“PHA analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the anatomy. The overall intended use of the devices are equivalent: to use deep-learning models to measure diameters of clinically relevant cardiovascular structures from a CTPA image.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Standalone

n=100 cases

endpoints: Intra-class correlation coefficients were calculated to show equivalency.

Reported performance (1 observation)

agreement_kappaas written: “ICC”0.94

source quote (p.7)

“The ICC between three expert radiologists and the algorithm results is 0.94, indicating excellent agreement.”

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).