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.”
AlgorithmFDA source did not state this
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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K161201