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FDA 510(k)

ARIETTA Prologue Diagnostic Ultrasound system and Transducers

K-Number: K162902 · 2016-12-15

ApplicantHitachi , Ltd.
Decision Date2016-12-15
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARIETTA Prologue Diagnostic Ultrasound system and Transducers is a medical device manufactured by Hitachi , Ltd.. It received FDA 510(k) clearance on 2016-12-15 under approval number K162902. 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 ARIETTA Prologue Diagnostic Ultrasound system and Transducers?

ARIETTA Prologue Diagnostic Ultrasound system and Transducers is a medical device that received FDA 510(k) clearance on 2016-12-15. It is manufactured by Hitachi , Ltd.. The 510(k) number is K162902.

When was ARIETTA Prologue Diagnostic Ultrasound system and Transducers approved by the FDA?

ARIETTA Prologue Diagnostic Ultrasound system and Transducers received FDA 510(k) clearance on 2016-12-15, under approval number K162902.

What company makes ARIETTA Prologue Diagnostic Ultrasound system and Transducers?

ARIETTA Prologue Diagnostic Ultrasound system and Transducers is manufactured by Hitachi , Ltd..

What is the FDA product code for ARIETTA Prologue Diagnostic Ultrasound system and Transducers?

The FDA product code for ARIETTA Prologue Diagnostic Ultrasound system and Transducers 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 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 Hitachi , Ltd.

K162583ALOKA LISENDO 880 K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory K172087SANGRAY K163505ARIETTA PRECISION K191801PROBEAT-CR K201042PROBEAT-CR

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Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., 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 K161999AixplorerSupersonic Imagine

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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