FDA 510(k)

SonoSite iViz Ultrasound System

K-Number: K162288 · 2016-09-08

Decision Date2016-09-08

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SonoSite iViz Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2016-09-08 under 510(k) 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. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K162288.

When did SonoSite iViz Ultrasound System receive FDA 510(k) clearance?

SonoSite iViz Ultrasound System received FDA 510(k) clearance on 2016-09-08, under 510(k) number K162288.

Who is the listed applicant for SonoSite iViz Ultrasound System?

The FDA 510(k) record lists FUJIFILM Sonosite, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SonoSite iViz Ultrasound System?

The FDA product code for SonoSite iViz Ultrasound System is IYN.

Other records listing FUJIFILM Sonosite, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260595Sonosite iLOOK Ultrasound System K253448Sonosite MT Ultrasound System K251106Sonosite LX and Sonosite PX Ultrasound Systems K251830Sonosite LX Ultrasound System K233597Sonosite LX Ultrasound System K213763Sonosite PX Ultrasound System

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Related Devices (Code: IYN)

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.