FDA 510(k)

CANON Fundus Camera CR-10 (CR-10)

K号: K241049 · 2024-05-15

决定日期2024-05-15

产品代码HKI

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决定实质等同

器械摘要

CANON Fundus Camera CR-10 (CR-10) is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2024-05-15 under 510(k) number K241049. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CANON Fundus Camera CR-10 (CR-10)?

CANON Fundus Camera CR-10 (CR-10) is a medical device that received FDA 510(k) clearance on 2024-05-15. The listed applicant is Canon, Inc.. The 510(k) number is K241049.

When did CANON Fundus Camera CR-10 (CR-10) receive FDA 510(k) clearance?

CANON Fundus Camera CR-10 (CR-10) received FDA 510(k) clearance on 2024-05-15, under 510(k) number K241049.

Who is the listed applicant for CANON Fundus Camera CR-10 (CR-10)?

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 CANON Fundus Camera CR-10 (CR-10)?

The FDA product code for CANON Fundus Camera CR-10 (CR-10) is HKI.

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 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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