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FDA 510(k)

Intelligent NR

K-Number: K252503 · 2026-04-30

ApplicantCanon, Inc.
Decision Date2026-04-30
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Intelligent NR is a medical device manufactured by Canon, Inc.. It received FDA 510(k) clearance on 2026-04-30 under approval number K252503. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intelligent NR?

Intelligent NR is a medical device that received FDA 510(k) clearance on 2026-04-30. It is manufactured by Canon, Inc.. The 510(k) number is K252503.

When was Intelligent NR approved by the FDA?

Intelligent NR received FDA 510(k) clearance on 2026-04-30, under approval number K252503.

What company makes Intelligent NR?

Intelligent NR is manufactured by Canon, Inc..

What is the FDA product code for Intelligent NR?

The FDA product code for Intelligent NR is OWB.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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