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FDA 510(k)

Digital Ultrasonic Diagnostic Imaging System (Model: F6)

K-Number: K231930 · 2024-03-22

ApplicantGuangdong Youkey Medical Co., Ltd.
Decision Date2024-03-22
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Digital Ultrasonic Diagnostic Imaging System (Model: F6) is a medical device manufactured by Guangdong Youkey Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-03-22 under approval number K231930. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Ultrasonic Diagnostic Imaging System (Model: F6)?

Digital Ultrasonic Diagnostic Imaging System (Model: F6) is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Guangdong Youkey Medical Co., Ltd.. The 510(k) number is K231930.

When was Digital Ultrasonic Diagnostic Imaging System (Model: F6) approved by the FDA?

Digital Ultrasonic Diagnostic Imaging System (Model: F6) received FDA 510(k) clearance on 2024-03-22, under approval number K231930.

What company makes Digital Ultrasonic Diagnostic Imaging System (Model: F6)?

Digital Ultrasonic Diagnostic Imaging System (Model: F6) is manufactured by Guangdong Youkey Medical Co., Ltd..

What is the FDA product code for Digital Ultrasonic Diagnostic Imaging System (Model: F6)?

The FDA product code for Digital Ultrasonic Diagnostic Imaging System (Model: F6) is IYN.

Related Clinical Trials

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Related PubMed Literature

PMID: 42207283 [Legal responsibility in AI-assisted radiological reporting]. Radiologie (Heidelberg, Germany) (2026) PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42037982 Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan. Digital health (2026)

Other Devices by Guangdong Youkey Medical Co., Ltd.

K211746Pocket Ultrasound System

Related Devices (Code: IYN)

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Official Source

View on FDA Database →

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