FDA 510(k)

数字放射摄影CXDI-Pro，数字放射摄影D1

K号: K222855 · 2022-10-17

决定日期2022-10-17

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

Digital Radiography CXDI-Pro, Digital Radiography D1 is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2022-10-17 under 510(k) number K222855. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Digital Radiography CXDI-Pro, Digital Radiography D1?

Digital Radiography CXDI-Pro, Digital Radiography D1 is a medical device that received FDA 510(k) clearance on 2022-10-17. The listed applicant is Canon, Inc.. The 510(k) number is K222855.

When did Digital Radiography CXDI-Pro, Digital Radiography D1 receive FDA 510(k) clearance?

Digital Radiography CXDI-Pro, Digital Radiography D1 received FDA 510(k) clearance on 2022-10-17, under 510(k) number K222855.

Who is the listed applicant for Digital Radiography CXDI-Pro, Digital Radiography D1?

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 Digital Radiography CXDI-Pro, Digital Radiography D1?

The FDA product code for Digital Radiography CXDI-Pro, Digital Radiography D1 is MQB.

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。

K252503智能NR K241049CANON Fundus Camera CR-10 (CR-10)K232298数字X光摄影 CXDI-RF 无线 K230175Digital Radiography CXDI-CS01 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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