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FDA 510(k)

SonoSite Edge II Ultrasound System

K-Number: K153626 · 2016-01-20

ApplicantFUJIFILM Sonosite, Inc.
Decision Date2016-01-20
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SonoSite Edge II 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 2016-01-20 under 510(k) number K153626. 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 Edge II Ultrasound System?

SonoSite Edge II Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K153626.

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

SonoSite Edge II Ultrasound System received FDA 510(k) clearance on 2016-01-20, under 510(k) number K153626.

Who is the listed applicant for SonoSite Edge II 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 Edge II Ultrasound System?

The FDA product code for SonoSite Edge II 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 SystemK253448Sonosite MT Ultrasound SystemK251106Sonosite LX and Sonosite PX Ultrasound SystemsK251830Sonosite LX Ultrasound SystemK233597Sonosite LX Ultrasound SystemK213763Sonosite PX Ultrasound System

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Related Devices (Code: IYN)

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.

K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCK261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care DiagnosticsK261288Handheld Ultrasound ScannerIMGFAX CO., LTD.K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;Samsung Medison Co., Ltd.K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC

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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