FDA 510(k)

智能NR

K号: K252503 · 2026-04-30

决定日期2026-04-30

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

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

常见问题

What is the Intelligent NR?

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

When did Intelligent NR receive FDA 510(k) clearance?

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

Who is the listed applicant for Intelligent NR?

The FDA 510(k) record lists Canon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intelligent NR?

The FDA product code for Intelligent NR is OWB.

列明Canon, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K241049CANON Fundus Camera CR-10 (CR-10)K232298数字X光摄影 CXDI-RF 无线 K230175Digital Radiography CXDI-CS01 K222855数字放射摄影CXDI-Pro，数字放射摄影D1 K222687数字放射摄影CXDI-Elite，数字放射摄影E1 K222661数字放射摄影CXDI-CS01

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