ImageSPECTRUM
K-Number: K201273 · 2020-09-25
ApplicantCanon, Inc.
Decision Date2020-09-25
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ImageSPECTRUM is a medical device manufactured by Canon, Inc.. It received FDA 510(k) clearance on 2020-09-25 under approval 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. It is manufactured by Canon, Inc.. The 510(k) number is K201273.
When was ImageSPECTRUM approved by the FDA?
ImageSPECTRUM received FDA 510(k) clearance on 2020-09-25, under approval number K201273.
What company makes ImageSPECTRUM?
ImageSPECTRUM is manufactured by Canon, Inc..
What is the FDA product code for ImageSPECTRUM?
The FDA product code for ImageSPECTRUM is NFJ.
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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.