FDA 510(k)

DeepX DermoSight Dermatoscope

K-Number: K230448 · 2023-05-17

Decision Date2023-05-17

Product CodePSN

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DeepX DermoSight Dermatoscope is the device name listed in this FDA 510(k) record. The listed applicant is Deepx Health, LLC. It received FDA 510(k) clearance on 2023-05-17 under 510(k) number K230448. 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 DeepX DermoSight Dermatoscope?

DeepX DermoSight Dermatoscope is a medical device that received FDA 510(k) clearance on 2023-05-17. The listed applicant is Deepx Health, LLC. The 510(k) number is K230448.

When did DeepX DermoSight Dermatoscope receive FDA 510(k) clearance?

DeepX DermoSight Dermatoscope received FDA 510(k) clearance on 2023-05-17, under 510(k) number K230448.

Who is the listed applicant for DeepX DermoSight Dermatoscope?

The FDA 510(k) record lists Deepx Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeepX DermoSight Dermatoscope?

The FDA product code for DeepX DermoSight Dermatoscope 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.

K213957Demetra Dermatoscope BDEM-01Barco N.V.K201408Demetra Analytics ToolkitBarco N.V.K192829Demetra BDEM-01 DermatoscopeBarco N.V.K180162VivaScope SystemCaliber Imaging & Diagnostics, Inc.

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.