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FDA 510(k)

SC1 Handheld Ultrasound Imaging system (Model: SC1)

K-Number: K233579 · 2024-06-26

ApplicantFcu Co., Ltd.
Decision Date2024-06-26
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SC1 Handheld Ultrasound Imaging system (Model: SC1) is a medical device manufactured by Fcu Co., Ltd.. It received FDA 510(k) clearance on 2024-06-26 under approval number K233579. 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 SC1 Handheld Ultrasound Imaging system (Model: SC1)?

SC1 Handheld Ultrasound Imaging system (Model: SC1) is a medical device that received FDA 510(k) clearance on 2024-06-26. It is manufactured by Fcu Co., Ltd.. The 510(k) number is K233579.

When was SC1 Handheld Ultrasound Imaging system (Model: SC1) approved by the FDA?

SC1 Handheld Ultrasound Imaging system (Model: SC1) received FDA 510(k) clearance on 2024-06-26, under approval number K233579.

What company makes SC1 Handheld Ultrasound Imaging system (Model: SC1)?

SC1 Handheld Ultrasound Imaging system (Model: SC1) is manufactured by Fcu Co., Ltd..

What is the FDA product code for SC1 Handheld Ultrasound Imaging system (Model: SC1)?

The FDA product code for SC1 Handheld Ultrasound Imaging system (Model: SC1) 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)

Other Devices by Fcu Co., Ltd.

K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)

Related Devices (Code: IYO)

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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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