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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 the device name listed in this FDA 510(k) record. The listed applicant is Michelson Diagnostics, Ltd.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) 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. The listed applicant is Michelson Diagnostics, Ltd.. The 510(k) number is K153283.

When did VivoSight Dx Topical OCT System receive FDA 510(k) clearance?

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

Who is the listed applicant for VivoSight Dx Topical OCT System?

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

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

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

Related Devices (Code: NQQ)

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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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