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FDA 510(k)

K3900 Ultrasound Imaging System

K-Number: K230511 · 2023-10-25

ApplicantMaui Imaging
Decision Date2023-10-25
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

K3900 Ultrasound Imaging System is a medical device manufactured by Maui Imaging. It received FDA 510(k) clearance on 2023-10-25 under approval number K230511. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K3900 Ultrasound Imaging System?

K3900 Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2023-10-25. It is manufactured by Maui Imaging. The 510(k) number is K230511.

When was K3900 Ultrasound Imaging System approved by the FDA?

K3900 Ultrasound Imaging System received FDA 510(k) clearance on 2023-10-25, under approval number K230511.

What company makes K3900 Ultrasound Imaging System?

K3900 Ultrasound Imaging System is manufactured by Maui Imaging.

What is the FDA product code for K3900 Ultrasound Imaging System?

The FDA product code for K3900 Ultrasound Imaging System is IYO.

Related Clinical Trials

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Related PubMed Literature

PMID: 41987469 [Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

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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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