Clever One
K250005Ewoosoft Co., Ltd · cleared 2025-05-23 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.4)
“Clever One is dental imaging software that is intended to provide tools for supporting diagnosis and treatment.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.12)
“In accordance with the FDA's guidance document, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions," comprehensive cybersecurity risk management and verification and validation activities were conducted. The results of these cybersecurity assessments, the supporting documentation, and the cybersecurity management plan are included in this premarket submission.”
Validation studies (1)
Bench
sample size not stated
endpoints: performance; functionality; reliability characteristics
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
3
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). 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).