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FDA 510(k)

OptosAdvance 4.0 Software

K-Number: K162039 · 2017-02-08

ApplicantOptos Plc.
Decision Date2017-02-08
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OptosAdvance 4.0 Software is the device name listed in this FDA 510(k) record. The listed applicant is Optos Plc.. It received FDA 510(k) clearance on 2017-02-08 under 510(k) number K162039. 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 OptosAdvance 4.0 Software?

OptosAdvance 4.0 Software is a medical device that received FDA 510(k) clearance on 2017-02-08. The listed applicant is Optos Plc.. The 510(k) number is K162039.

When did OptosAdvance 4.0 Software receive FDA 510(k) clearance?

OptosAdvance 4.0 Software received FDA 510(k) clearance on 2017-02-08, under 510(k) number K162039.

Who is the listed applicant for OptosAdvance 4.0 Software?

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

What is the FDA product code for OptosAdvance 4.0 Software?

The FDA product code for OptosAdvance 4.0 Software is NFJ.

Related Clinical Trials

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.

NCT05844852P200TE US Reference Database StudyCOMPLETEDNCT06269666P200TxE Diseased Eye Image CollectionCOMPLETED

Other records listing Optos Plc. 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.

K233602P200TE (A10700)K231673P200TE (A10700)K190732P200TxEK173707P200TE

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, AGK253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA OyK234076iCare ALTIUS CWCentervue S.P.A.K232828IMAGEnet6 Ophthalmic Data SystemTopcon CorporationK232944CALLISTO eyeCarl Zeiss Meditec, AGK232555HarmonyTopcon 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.

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