Auto Lung Nodule Detection

K201560

Samsung Electronics Co.,Ltd. · cleared 2021-08-31 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“The Auto Lung Nodule Detection is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 10 to 30 mm in size.”

AlgorithmMachine learning

source quote (p.6)

“Machine learning”

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: sensitivity; false positives per image (FPPI); jackknife alternative free response receiver operating characteristic (JAFROC) figure of merit (FOM)

standards: ISO14971:2007, IEC62304:2006, IEC62366-1:2015

Reported performance (1 observation)

false_positive_rate_per_imageas written: “false positives per image (FPPI)”stated without value

source quote (p.7)

“Nodule detection performances before and after ALND were measured via sensitivity, false positives per image (FPPI), and jackknife alternative free response receiver operating characteristic (JAFROC) figure of merit (FOM).”

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

-100%

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).