Radiology · 510(k) · 2026
Intelligent NR
Canon, Inc.. Cleared by FDA on 30 April 2026 under submission K252503, product code OWB (interventional fluoroscopic x-ray system). What FDA's record says, in FDA's words.
Device record · K252503
- Device. Intelligent NRDEVICE
- Company. Canon, Inc. (JP)COMPANY
- Decision. 30 April 2026, 510(k), substantially equivalent (traditional review); received 8 August 2025DECISION
- Panel. RadiologyPANEL
- Product code. OWB, Interventional Fluoroscopic X-Ray SystemCODE
- Regulation. 21 CFR 892.1650, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
As a part of the Canon radiography system, the CXDI Control Software when used with a compatible Canon detector is intended to provide digital image capture, processing, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. It is also used for generating fluoroscopic images, when integrated into the X-ray diagnostic systems, to replace the spot-film devices and the X-ray image intensifiers. As part of the CXDI Control Software, the Intelligent NR utilizes artificial intelligence based algorithms to reduce noise in fluoroscopic images. Not intended for mammography applications.
The product code's definition, from FDA's classification record. Interventional fluoroscopy
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedradiographs (X-ray)
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 50,680 reports filed against devices carrying product code OWB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002661
It was reported to Philips that the system was unable to start up properly.The system was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002659
It was reported to Philips that the system was experiencing booting issues.The system was not in clinical use during the event. No harm was reported to the user or the patient during the event.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002662
It was reported to Philips that the system was unable to perform exposure.The system was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD20 · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002664
It was reported to Philips that the system's propellor geometry movement was not available.The device was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002665
It was reported to Philips that the system could not emit X-ray.The device was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OWB, in Radiology, from Canon, Inc., or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.