SonoSite iViz Ultrasound System
K-Number: K162288 · 2016-09-08
ApplicantFUJIFILM Sonosite, Inc.
Decision Date2016-09-08
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SonoSite iViz Ultrasound System is a medical device manufactured by FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2016-09-08 under approval number K162288. 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 SonoSite iViz Ultrasound System?
SonoSite iViz Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-09-08. It is manufactured by FUJIFILM Sonosite, Inc.. The 510(k) number is K162288.
When was SonoSite iViz Ultrasound System approved by the FDA?
SonoSite iViz Ultrasound System received FDA 510(k) clearance on 2016-09-08, under approval number K162288.
What company makes SonoSite iViz Ultrasound System?
SonoSite iViz Ultrasound System is manufactured by FUJIFILM Sonosite, Inc..
What is the FDA product code for SonoSite iViz Ultrasound System?
The FDA product code for SonoSite iViz Ultrasound System is IYN.
Related Clinical Trials
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
NCT04981223
Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
COMPLETED
NCT06559891
THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension
RECRUITING
NCT07095660
RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL)
RECRUITING
NCT06253858
Ultrasound (US) Guided External Ventricular Catheter Placement
RECRUITING
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.