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FDA 510(k)

DeepTek CXR Analyzer v1.0

K-Number: K231001 · 2023-10-05

ApplicantDeeptek Medical Imaging Pvt, Ltd.
Decision Date2023-10-05
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DeepTek CXR Analyzer v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Deeptek Medical Imaging Pvt, Ltd.. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K231001. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DeepTek CXR Analyzer v1.0?

DeepTek CXR Analyzer v1.0 is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is Deeptek Medical Imaging Pvt, Ltd.. The 510(k) number is K231001.

When did DeepTek CXR Analyzer v1.0 receive FDA 510(k) clearance?

DeepTek CXR Analyzer v1.0 received FDA 510(k) clearance on 2023-10-05, under 510(k) number K231001.

Who is the listed applicant for DeepTek CXR Analyzer v1.0?

The FDA 510(k) record lists Deeptek Medical Imaging Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeepTek CXR Analyzer v1.0?

The FDA product code for DeepTek CXR Analyzer v1.0 is MYN.

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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.

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