FDA 510(k)

Afina

K-Number: K181501 · 2018-11-02

Decision Date2018-11-02

Product CodeNFJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Afina is the device name listed in this FDA 510(k) record. The listed applicant is Neurovision Imaging, LLC. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K181501. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Afina?

Afina is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Neurovision Imaging, LLC. The 510(k) number is K181501.

When did Afina receive FDA 510(k) clearance?

Afina received FDA 510(k) clearance on 2018-11-02, under 510(k) number K181501.

Who is the listed applicant for Afina?

The FDA 510(k) record lists Neurovision Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Afina?

The FDA product code for Afina is NFJ.

Related Devices (Code: NFJ)

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.

K260694ZEISS CLINIC 360Carl Zeiss Meditec, AG K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy K234076iCare ALTIUS CWCentervue S.P.A.K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation K232944CALLISTO eyeCarl Zeiss Meditec, AG K232555HarmonyTopcon Healthcare Solutions

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.