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FDA 510(k)

VistaScan USB Ultrasound Imaging System

K-Number: K192170 · 2020-01-23

ApplicantEmagine Solutions Technology, LLC
Decision Date2020-01-23
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VistaScan USB Ultrasound Imaging System is a medical device manufactured by Emagine Solutions Technology, LLC. It received FDA 510(k) clearance on 2020-01-23 under approval number K192170. 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 VistaScan USB Ultrasound Imaging System?

VistaScan USB Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2020-01-23. It is manufactured by Emagine Solutions Technology, LLC. The 510(k) number is K192170.

When was VistaScan USB Ultrasound Imaging System approved by the FDA?

VistaScan USB Ultrasound Imaging System received FDA 510(k) clearance on 2020-01-23, under approval number K192170.

What company makes VistaScan USB Ultrasound Imaging System?

VistaScan USB Ultrasound Imaging System is manufactured by Emagine Solutions Technology, LLC.

What is the FDA product code for VistaScan USB Ultrasound Imaging System?

The FDA product code for VistaScan USB Ultrasound Imaging System is IYO.

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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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