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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 a medical device manufactured by Optos Plc.. It received FDA 510(k) clearance on 2017-02-08 under approval 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. It is manufactured by Optos Plc.. The 510(k) number is K162039.

When was OptosAdvance 4.0 Software approved by the FDA?

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

What company makes OptosAdvance 4.0 Software?

OptosAdvance 4.0 Software is manufactured by Optos Plc..

What is the FDA product code for OptosAdvance 4.0 Software?

The FDA product code for OptosAdvance 4.0 Software is NFJ.

Other Devices by Optos Plc.

K173707P200TE K190732P200TxE K231673P200TE (A10700) K233602P200TE (A10700)

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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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