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FDA 510(k)

EchoSure Diagnostic Ultrasound System

K-Number: K190039 · 2019-03-08

ApplicantSonavex, Inc.
Decision Date2019-03-08
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoSure Diagnostic Ultrasound System is a medical device manufactured by Sonavex, Inc.. It received FDA 510(k) clearance on 2019-03-08 under approval number K190039. 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 EchoSure Diagnostic Ultrasound System?

EchoSure Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-03-08. It is manufactured by Sonavex, Inc.. The 510(k) number is K190039.

When was EchoSure Diagnostic Ultrasound System approved by the FDA?

EchoSure Diagnostic Ultrasound System received FDA 510(k) clearance on 2019-03-08, under approval number K190039.

What company makes EchoSure Diagnostic Ultrasound System?

EchoSure Diagnostic Ultrasound System is manufactured by Sonavex, Inc..

What is the FDA product code for EchoSure Diagnostic Ultrasound System?

The FDA product code for EchoSure Diagnostic Ultrasound System is IYO.

Related Clinical Trials

NCT07040696 Accuracy of Venous Excess Ultrasound Score at Hospital Admission to Predict Acute Kidney Injury COMPLETED NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT05857852 Low-Intensity Focused Ultrasound for Cocaine Use Disorder COMPLETED NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07608614 Sleep and Performance RECRUITING

Related PubMed Literature

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: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Other Devices by Sonavex, Inc.

K180621EchoMark, EchoMark LP K243479EchoGuide (Version 1)

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

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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