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FDA 510(k)

SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System

K-Number: K162045 · 2016-08-18

ApplicantFUJIFILM Sonosite, Inc.
Decision Date2016-08-18
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System is a medical device manufactured by FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2016-08-18 under approval number K162045. 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 SII Ultrasound System, SonoSite Edge II Ultrasound System?

SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-08-18. It is manufactured by FUJIFILM Sonosite, Inc.. The 510(k) number is K162045.

When was SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System approved by the FDA?

SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System received FDA 510(k) clearance on 2016-08-18, under approval number K162045.

What company makes SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System?

SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System is manufactured by FUJIFILM Sonosite, Inc..

What is the FDA product code for SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System?

The FDA product code for SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System is IYN.

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Other Devices by FUJIFILM Sonosite, Inc.

K162288SonoSite iViz Ultrasound System K161119SonoSite iViz Ultrasound System K160674Fujifilm Sonosite Vevo MD Imaging System K160734SonoSite SII Ultrasound System K160406FUJIFILM FC1 Ultrasound System K153626SonoSite Edge II Ultrasound System

View all 19 devices →

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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