Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Deeptek Medical Imaging Pvt, Ltd.. It received FDA 510(k) clearance on 2023-10-05 under approval 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. It is manufactured by Deeptek Medical Imaging Pvt, Ltd.. The 510(k) number is K231001.

When was DeepTek CXR Analyzer v1.0 approved by the FDA?

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

What company makes DeepTek CXR Analyzer v1.0?

DeepTek CXR Analyzer v1.0 is manufactured by Deeptek Medical Imaging Pvt, Ltd..

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

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

Related Devices (Code: MYN)

K201560Auto Lung Nodule DetectionSamsung Electronics Co., Ltd. K210666Chest-CADImagen Technologies, Inc. K220928Overjet Calculus AssistOverjet, Inc. K213353Aorta-CADImagen Technologies, Inc. K212519Overjet Caries AssistOverjet, Inc. K213795Videa Caries AssistVideahealth, Inc.

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.

↑