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FDA 510(k)

AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems

K-Number: K171105 · 2017-07-11

ApplicantSupersonic Imagine
Decision Date2017-07-11
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems is the device name listed in this FDA 510(k) record. The listed applicant is Supersonic Imagine. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K171105. 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 AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems?

AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is Supersonic Imagine. The 510(k) number is K171105.

When did AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems receive FDA 510(k) clearance?

AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems received FDA 510(k) clearance on 2017-07-11, under 510(k) number K171105.

Who is the listed applicant for AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems?

The FDA 510(k) record lists Supersonic Imagine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems?

The FDA product code for AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems is IYN.

Other records listing Supersonic Imagine 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.

K242223SuperSonic HepaVuK222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic SystemsK191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsK180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10

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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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