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FDA 510(k)

Canon non-mydriatic retinal camera CR series

K-Number: K201122 · 2020-07-23

ApplicantCanon, Inc.
Decision Date2020-07-23
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Canon non-mydriatic retinal camera CR series is a medical device manufactured by Canon, Inc.. It received FDA 510(k) clearance on 2020-07-23 under approval number K201122. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Canon non-mydriatic retinal camera CR series?

Canon non-mydriatic retinal camera CR series is a medical device that received FDA 510(k) clearance on 2020-07-23. It is manufactured by Canon, Inc.. The 510(k) number is K201122.

When was Canon non-mydriatic retinal camera CR series approved by the FDA?

Canon non-mydriatic retinal camera CR series received FDA 510(k) clearance on 2020-07-23, under approval number K201122.

What company makes Canon non-mydriatic retinal camera CR series?

Canon non-mydriatic retinal camera CR series is manufactured by Canon, Inc..

What is the FDA product code for Canon non-mydriatic retinal camera CR series?

The FDA product code for Canon non-mydriatic retinal camera CR series is HKI.

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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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