Fujifilm Sonosite Vevo MD Imaging System
K-Number: K160674 · 2016-04-19
ApplicantFUJIFILM Sonosite, Inc.
Decision Date2016-04-19
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Fujifilm Sonosite Vevo MD Imaging System is a medical device manufactured by FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2016-04-19 under approval number K160674. 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 Fujifilm Sonosite Vevo MD Imaging System?
Fujifilm Sonosite Vevo MD Imaging System is a medical device that received FDA 510(k) clearance on 2016-04-19. It is manufactured by FUJIFILM Sonosite, Inc.. The 510(k) number is K160674.
When was Fujifilm Sonosite Vevo MD Imaging System approved by the FDA?
Fujifilm Sonosite Vevo MD Imaging System received FDA 510(k) clearance on 2016-04-19, under approval number K160674.
What company makes Fujifilm Sonosite Vevo MD Imaging System?
Fujifilm Sonosite Vevo MD Imaging System is manufactured by FUJIFILM Sonosite, Inc..
What is the FDA product code for Fujifilm Sonosite Vevo MD Imaging System?
The FDA product code for Fujifilm Sonosite Vevo MD Imaging System is IYN.
Related Clinical Trials
NCT01143454
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
RECRUITING
NCT03331380
Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
RECRUITING
NCT04981223
Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
COMPLETED
NCT07608614
Sleep and Performance
RECRUITING
NCT06861309
Placental Imaging Techniques
RECRUITING
NCT05225935
Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia
COMPLETED
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: 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: 40346298
An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients.
NPJ digital medicine (2025)
Other Devices by FUJIFILM Sonosite, Inc.
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.