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FDA 510(k)

ImageSPECTRUM

K-Number: K201273 · 2020-09-25

ApplicantCanon, Inc.
Decision Date2020-09-25
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Canon, Inc. as applicant

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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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