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FDA 510(k)

Lung-CAD

K-Number: K230085 · 2023-10-03

ApplicantImagen Technologies, Inc.
Decision Date2023-10-03
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Lung-CAD is a medical device manufactured by Imagen Technologies, Inc.. It received FDA 510(k) clearance on 2023-10-03 under approval number K230085. 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 Lung-CAD?

Lung-CAD is a medical device that received FDA 510(k) clearance on 2023-10-03. It is manufactured by Imagen Technologies, Inc.. The 510(k) number is K230085.

When was Lung-CAD approved by the FDA?

Lung-CAD received FDA 510(k) clearance on 2023-10-03, under approval number K230085.

What company makes Lung-CAD?

Lung-CAD is manufactured by Imagen Technologies, Inc..

What is the FDA product code for Lung-CAD?

The FDA product code for Lung-CAD is MYN.

Other Devices by Imagen Technologies, Inc.

DEN180005OsteoDetect K193417FractureDetect (FX) K210666Chest-CAD K213353Aorta-CAD K223811Lung-CAD

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.

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