Intelligent NR
K212269Canon Inc. · cleared 2021-09-17 · product code MQB · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.4)
“The Intelligent NR (Intelligent Noise Reduction) function is a part of the CXDI Control software for the Canon detectors (with version 3.10 of the CXDI Control Software) that makes use of the Intelligent NR function to reduce noise for X-ray images taken using the Canon detectors. ... The Intelligent NR function works on a PC and displays to a monitor.”
Algorithmmachine-learning
source quote (p.4)
“The Intelligent NR function was developed using machine-learning and trained by using an existing clinical image database to learn the characteristics of noises and create noise reduced images.”
Adaptive (vs locked)No
source quote (p.4)
“The Intelligent NR function does not perform machine learning after release to users.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (0)
FDA source did not describe a validation study.
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
2
recalls in product code, 24mo
75
MAUDE reports in code, 12mo
+2%
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).