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FDA 510(k)

Optina-4C (MHRC-C1N)

K-Number: K250770 · 2025-09-04

ApplicantOptina Diagnostics, Inc.
Decision Date2025-09-04
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Optina-4C (MHRC-C1N) is the device name listed in this FDA 510(k) record. The listed applicant is Optina Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K250770. 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 Optina-4C (MHRC-C1N)?

Optina-4C (MHRC-C1N) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Optina Diagnostics, Inc.. The 510(k) number is K250770.

When did Optina-4C (MHRC-C1N) receive FDA 510(k) clearance?

Optina-4C (MHRC-C1N) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K250770.

Who is the listed applicant for Optina-4C (MHRC-C1N)?

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

What is the FDA product code for Optina-4C (MHRC-C1N)?

The FDA product code for Optina-4C (MHRC-C1N) is HKI.

Other records listing Optina Diagnostics, Inc. 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.

K231230Optina-4C (MHRC-C1N)K200254Mydriatic Hyperspectral Retinal Camera (MHRC-C1)

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 LimitedK2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.K243664Sentinel CameraAi Optics

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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