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FDA 510(k)

Imagio Ultrasound Imaging System

K-Number: K182628 · 2019-03-05

ApplicantSeno Medical Instruments, Inc.
Decision Date2019-03-05
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Imagio Ultrasound Imaging System is a medical device manufactured by Seno Medical Instruments, Inc.. It received FDA 510(k) clearance on 2019-03-05 under approval number K182628. 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 Imagio Ultrasound Imaging System?

Imagio Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2019-03-05. It is manufactured by Seno Medical Instruments, Inc.. The 510(k) number is K182628.

When was Imagio Ultrasound Imaging System approved by the FDA?

Imagio Ultrasound Imaging System received FDA 510(k) clearance on 2019-03-05, under approval number K182628.

What company makes Imagio Ultrasound Imaging System?

Imagio Ultrasound Imaging System is manufactured by Seno Medical Instruments, Inc..

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

The FDA product code for Imagio Ultrasound Imaging System is IYN.

Related Clinical Trials

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Related PubMed Literature

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: 32530098 Introduction to artificial intelligence in ultrasound imaging in obstetrics and gynecology. Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology (2020)

Other Devices by Seno Medical Instruments, Inc.

PMA P200003Optoacoustic Imaging System

Related Devices (Code: IYN)

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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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