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FDA 510(k)

Mydriatic Hyperspectral Retinal Camera (MHRC-C1)

K-Number: K200254 · 2020-04-27

ApplicantOptina Diagnostics
Decision Date2020-04-27
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is the device name listed in this FDA 510(k) record. The listed applicant is Optina Diagnostics. It received FDA 510(k) clearance on 2020-04-27 under 510(k) number K200254. 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 Mydriatic Hyperspectral Retinal Camera (MHRC-C1)?

Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is a medical device that received FDA 510(k) clearance on 2020-04-27. The listed applicant is Optina Diagnostics. The 510(k) number is K200254.

When did Mydriatic Hyperspectral Retinal Camera (MHRC-C1) receive FDA 510(k) clearance?

Mydriatic Hyperspectral Retinal Camera (MHRC-C1) received FDA 510(k) clearance on 2020-04-27, under 510(k) number K200254.

Who is the listed applicant for Mydriatic Hyperspectral Retinal Camera (MHRC-C1)?

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

What is the FDA product code for Mydriatic Hyperspectral Retinal Camera (MHRC-C1)?

The FDA product code for Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is HKI.

Other records listing Optina Diagnostics as applicant

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.

K250770Optina-4C (MHRC-C1N)K231230Optina-4C (MHRC-C1N)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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