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FDA 510(k)

DeepXray

K-Number: K223621 · 2023-09-08

ApplicantAlpha Intelligence Manifolds, Inc.
Decision Date2023-09-08
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DeepXray is a medical device manufactured by Alpha Intelligence Manifolds, Inc.. It received FDA 510(k) clearance on 2023-09-08 under approval number K223621. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DeepXray?

DeepXray is a medical device that received FDA 510(k) clearance on 2023-09-08. It is manufactured by Alpha Intelligence Manifolds, Inc.. The 510(k) number is K223621.

When was DeepXray approved by the FDA?

DeepXray received FDA 510(k) clearance on 2023-09-08, under approval number K223621.

What company makes DeepXray?

DeepXray is manufactured by Alpha Intelligence Manifolds, Inc..

What is the FDA product code for DeepXray?

The FDA product code for DeepXray is QIH.

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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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