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FDA 510(k)

ULTIMUS Series Ultrasound Diagnostic System

K-Number: K240676 · 2024-12-16

ApplicantVinno Technology (Suzhou) Co.,Ltd
Decision Date2024-12-16
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTIMUS Series Ultrasound Diagnostic System is a medical device manufactured by Vinno Technology (Suzhou) Co.,Ltd. It received FDA 510(k) clearance on 2024-12-16 under approval number K240676. 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 ULTIMUS Series Ultrasound Diagnostic System?

ULTIMUS Series Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2024-12-16. It is manufactured by Vinno Technology (Suzhou) Co.,Ltd. The 510(k) number is K240676.

When was ULTIMUS Series Ultrasound Diagnostic System approved by the FDA?

ULTIMUS Series Ultrasound Diagnostic System received FDA 510(k) clearance on 2024-12-16, under approval number K240676.

What company makes ULTIMUS Series Ultrasound Diagnostic System?

ULTIMUS Series Ultrasound Diagnostic System is manufactured by Vinno Technology (Suzhou) Co.,Ltd.

What is the FDA product code for ULTIMUS Series Ultrasound Diagnostic System?

The FDA product code for ULTIMUS Series Ultrasound Diagnostic System is IYN.

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 NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss 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

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026)

Other Devices by Vinno Technology (Suzhou) Co.,Ltd

K190120VINNO 8, VINNO 6, VINNO 5 K221911VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP K230160VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E K223917VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P K223920VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P

Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

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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