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FDA 510(k)

VivoSight Dx Topical OCT System

K-Number: K153283 · 2016-08-11

ApplicantMichelson Diagnostics, Ltd.
Decision Date2016-08-11
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VivoSight Dx Topical OCT System is a medical device manufactured by Michelson Diagnostics, Ltd.. It received FDA 510(k) clearance on 2016-08-11 under approval number K153283. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VivoSight Dx Topical OCT System?

VivoSight Dx Topical OCT System is a medical device that received FDA 510(k) clearance on 2016-08-11. It is manufactured by Michelson Diagnostics, Ltd.. The 510(k) number is K153283.

When was VivoSight Dx Topical OCT System approved by the FDA?

VivoSight Dx Topical OCT System received FDA 510(k) clearance on 2016-08-11, under approval number K153283.

What company makes VivoSight Dx Topical OCT System?

VivoSight Dx Topical OCT System is manufactured by Michelson Diagnostics, Ltd..

What is the FDA product code for VivoSight Dx Topical OCT System?

The FDA product code for VivoSight Dx Topical OCT System is NQQ.

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Official Source

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