FDA 510(k)

ImageSPECTRUM

K号: K201273 · 2020-09-25

决定日期2020-09-25

产品代码NFJ

咨询委员会RA

决定实质等同

器械摘要

ImageSPECTRUM is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2020-09-25 under 510(k) number K201273. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ImageSPECTRUM?

ImageSPECTRUM is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Canon, Inc.. The 510(k) number is K201273.

When did ImageSPECTRUM receive FDA 510(k) clearance?

ImageSPECTRUM received FDA 510(k) clearance on 2020-09-25, under 510(k) number K201273.

Who is the listed applicant for ImageSPECTRUM?

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 ImageSPECTRUM?

The FDA product code for ImageSPECTRUM is NFJ.

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 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

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