Intelligent NR— 510(k) K252503
Substantially EquivalentCanon, Inc.
FDA 510(k) clearance K252503 for Intelligent NR, Substantially Equivalent on 2026-04-30. Applicant: Canon, Inc.. Device class: 2.
Summary
Canon's Intelligent NR is filed under product code OWB (Interventional Fluoroscopic X-Ray System). The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 892.1650. It came in as a Traditional 510(k), and Radiology is both the classification panel and the review panel.
Canon filed from Tokyo, Japan. Review took 265 calendar days (August 8, 2025 to April 30, 2026).
Clearance details
- Applicant
- Canon, Inc.
- Product code
- Product code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code OWB
view allMore clearances from Canon, Inc.
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.