ClearRead CT

K161201

RIVERAIN TECHNOLOGIES, LLC · cleared 2016-09-09 · product code OEB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“ClearRead CT is a dedicated post-processing application that generates a secondary vessel suppressed Lung CT series with CADe marks and associated region descriptors intended to aid the radiologist in the detection of pulmonary nodules.”

Algorithmdedicated post-processing application that generates a secondary vessel suppressed Lung CT series with CADe marks and associated region descriptors intended to aid the radiologist in the detection of pulmonary nodules

source quote (p.4)

“ClearRead CT is a dedicated post-processing application that generates a secondary vessel suppressed Lung CT series with CADe marks and associated region descriptors intended to aid the radiologist in the detection of pulmonary nodules.”

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)

Reader study (MRMC)

sample size not stated

endpoints: area under the curve (AUC) of the localization receiver operating characteristic (LROC) response; radiologists' interpretation time

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) K242188 (decision 2024-12-03) from Riverain Technologies, Inc. for a matching device line ("ClearRead CT CAC") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K242188
re_clearance
The FDA AI/ML device list shows a newer 510(k) K213566 (decision 2022-03-10) from Riverain Technologies, Inc. for a matching device line ("ClearRead Xray Pneumothorax") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K213566

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).