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FDA 510(k)

VivaScope System

K-Number: K180162 · 2018-05-03

ApplicantCaliber Imaging & Diagnostics, Inc.
Decision Date2018-05-03
Product CodePSN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VivaScope System is a medical device manufactured by Caliber Imaging & Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-05-03 under approval number K180162. The device is classified under product code PSN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VivaScope System?

VivaScope System is a medical device that received FDA 510(k) clearance on 2018-05-03. It is manufactured by Caliber Imaging & Diagnostics, Inc.. The 510(k) number is K180162.

When was VivaScope System approved by the FDA?

VivaScope System received FDA 510(k) clearance on 2018-05-03, under approval number K180162.

What company makes VivaScope System?

VivaScope System is manufactured by Caliber Imaging & Diagnostics, Inc..

What is the FDA product code for VivaScope System?

The FDA product code for VivaScope System is PSN.

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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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