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 the device name listed in this FDA 510(k) record. The listed applicant is Caliber Imaging & Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-05-03 under 510(k) 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. The listed applicant is Caliber Imaging & Diagnostics, Inc.. The 510(k) number is K180162.

When did VivaScope System receive FDA 510(k) clearance?

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

Who is the listed applicant for VivaScope System?

The FDA 510(k) record lists Caliber Imaging & Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VivaScope System?

The FDA product code for VivaScope System is PSN.

Related Devices (Code: PSN)

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.

K230448DeepX DermoSight DermatoscopeDeepx Health, LLC K213957Demetra Dermatoscope BDEM-01Barco N.V.K201408Demetra Analytics ToolkitBarco N.V.K192829Demetra BDEM-01 DermatoscopeBarco N.V.

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.