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FDA 510(k)

Non-Mydriatic Retinal Camera NW500

K-Number: K221111 · 2022-08-29

ApplicantTopcon Corporation
Decision Date2022-08-29
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Non-Mydriatic Retinal Camera NW500 is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corporation. It received FDA 510(k) clearance on 2022-08-29 under 510(k) number K221111. 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 Non-Mydriatic Retinal Camera NW500?

Non-Mydriatic Retinal Camera NW500 is a medical device that received FDA 510(k) clearance on 2022-08-29. The listed applicant is Topcon Corporation. The 510(k) number is K221111.

When did Non-Mydriatic Retinal Camera NW500 receive FDA 510(k) clearance?

Non-Mydriatic Retinal Camera NW500 received FDA 510(k) clearance on 2022-08-29, under 510(k) number K221111.

Who is the listed applicant for Non-Mydriatic Retinal Camera NW500?

The FDA 510(k) record lists Topcon Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-Mydriatic Retinal Camera NW500?

The FDA product code for Non-Mydriatic Retinal Camera NW500 is HKI.

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Related Devices (Code: 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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