Intelligent NR
FDA 510(k) K252503 · Canon, Inc.
510(k) numberK252503
Submission
- Device name
- Intelligent NR
- Applicant
- Canon, Inc.
Tokyo, JP - Received
- August 8, 2025
- Decision date
- April 30, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Intelligent NR cleared by the FDA?
Intelligent NR (K252503) received a 510(k) decision of Substantially Equivalent on April 30, 2026, 265 days after the submission was received.
What is the product code of K252503?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.