FDA 510(k)

DeepCT

K-Number: K182875 · 2019-07-10

Decision Date2019-07-10

Product CodeQAS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DeepCT is the device name listed in this FDA 510(k) record. The listed applicant is Deep01 Limited. It received FDA 510(k) clearance on 2019-07-10 under 510(k) number K182875. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DeepCT?

DeepCT is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is Deep01 Limited. The 510(k) number is K182875.

When did DeepCT receive FDA 510(k) clearance?

DeepCT received FDA 510(k) clearance on 2019-07-10, under 510(k) number K182875.

Who is the listed applicant for DeepCT?

The FDA 510(k) record lists Deep01 Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeepCT?

The FDA product code for DeepCT is QAS.

Related Devices (Code: QAS)

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.

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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.