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FDA-cleared K252503

Intelligent NR

Canon, Inc.

Authorized purpose: Canon Intelligent NR is a noise-reduction function for fluoroscopic images acquired on compatible Canon radiography and fluoroscopy systems.

Modality
Fluoroscopy/Angiography
Anatomy
Whole body; diagnostic and interventional anatomy
Decision
2026-04-30
FDA-cleared K212269

Intelligent NR

Canon Inc.

Authorized purpose: Intelligent NR is a radiographic image-processing function for supported X-ray studies in the exact K212269 workflow; processed images are reviewed by qualified professionals and do not establish a product-wide diagnostic-performance claim.

Modality
X-ray/Radiography
Anatomy
Chest and other labeled radiographic anatomy
Decision
2021-09-17