Intelligent NR

K212269

Canon 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 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. The Intelligent NR function does not perform machine learning after release to users. The CXDI control software, which Intelligent NR is a part of, provides system control, controls GUI on the monitor, and processes images. 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.”
PCCPNo
Cybersecurity addressedNo

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); 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/K212269