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FDA 510(k)

Aixplorer

K-Number: K161999 · 2016-11-16

ApplicantSupersonic Imagine
Decision Date2016-11-16
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aixplorer is a medical device manufactured by Supersonic Imagine. It received FDA 510(k) clearance on 2016-11-16 under approval number K161999. 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 is a medical device that received FDA 510(k) clearance on 2016-11-16. It is manufactured by Supersonic Imagine. The 510(k) number is K161999.

When was Aixplorer approved by the FDA?

Aixplorer received FDA 510(k) clearance on 2016-11-16, under approval number K161999.

What company makes Aixplorer?

Aixplorer is manufactured by Supersonic Imagine.

What is the FDA product code for Aixplorer?

The FDA product code for Aixplorer is IYN.

Other Devices by Supersonic Imagine

K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40

View all 9 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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