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FDA 510(k)

NOBLUS™ Ultrasound Diagnostic System

K-Number: K160559 · 2016-10-18

ApplicantHitachi Medical Corporation
Decision Date2016-10-18
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NOBLUS™ Ultrasound Diagnostic System is a medical device manufactured by Hitachi Medical Corporation. It received FDA 510(k) clearance on 2016-10-18 under approval number K160559. 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 NOBLUS™ Ultrasound Diagnostic System?

NOBLUS™ Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2016-10-18. It is manufactured by Hitachi Medical Corporation. The 510(k) number is K160559.

When was NOBLUS™ Ultrasound Diagnostic System approved by the FDA?

NOBLUS™ Ultrasound Diagnostic System received FDA 510(k) clearance on 2016-10-18, under approval number K160559.

What company makes NOBLUS™ Ultrasound Diagnostic System?

NOBLUS™ Ultrasound Diagnostic System is manufactured by Hitachi Medical Corporation.

What is the FDA product code for NOBLUS™ Ultrasound Diagnostic System?

The FDA product code for NOBLUS™ 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 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 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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