InferRead Lung CT.AI

K192880

Beijing Infervision Technology Co.,Ltd. · cleared 2020-07-02 · product code OEB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“InferRead Lung CT.AI uses the Browser/Server architecture, and is provided as Software as a Service (SaaS) via a URL. The system integrates algorithm logic and database in the same server to ensure the simplicity of the system and the convenience of system maintenance. The server is able to accept chest CT images from a PACS system, Radiological Information System (RIS system) or directly from a CT scanner, analyze the images and provide output annotations regarding lung nodules.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: reproducibility; accuracy; detection accuracy; nodule detection sensitivity; FP/scan

standards: General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002)

Reader study (MRMC)

n=249 scans

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

Reported performance (1 observation)

aurocas written: “Increase in AUC (Aided - Unaided)”0.073CI 0.020, 0.125
source quote (p.9)
“Results showed that InferRead Lung CT.AI was found to significantly increase the AUC (Aided - Unaided: 0.073, 95%CI: 0.020, 0.125), indicating the detection performance through using the device is superior to the unaided read for detecting nodules.”

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
0
drift signals on this device

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/K192880