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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 the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2020-07-23 under 510(k) 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. The listed applicant is Canon, Inc.. The 510(k) number is K201122.

When did Canon non-mydriatic retinal camera CR series receive FDA 510(k) clearance?

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

Who is the listed applicant for Canon non-mydriatic retinal camera CR series?

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 non-mydriatic retinal camera CR series?

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

Other records listing Canon, Inc. as applicant

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Related Devices (Code: HKI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

Official Source

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