K252503
- 510(k) number
- K252503
- Device name
- Intelligent NR
- Applicant
- Canon, Inc. JP
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2026-04-30
- Date received
- 2025-08-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K252503.pdf
Official FDA record: K252503
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.