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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 a medical device manufactured by Supersonic Imagine. It received FDA 510(k) clearance on 2017-07-11 under approval 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. It is manufactured by Supersonic Imagine. The 510(k) number is K171105.

When was AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems approved by the FDA?

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

What company makes AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems?

AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems is manufactured by Supersonic Imagine.

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

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

Related Clinical Trials

NCT07207356 Ultrasound Guided Transcutaneous Pulsed Radiofrequency for Cervical Radiculopathy RECRUITING NCT06550193 Augmented Reality/Virtual Reality (AR/VR) for Ultrasound-guided Medical Procedures RECRUITING NCT06071715 Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation COMPLETED NCT07508722 Transcranial Ultrasonic Neuromodulation of Primary Visual Cortex and Primary Auditory Cortex in Humans NOT_YET_RECRUITING NCT05432999 Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury COMPLETED

Other Devices by Supersonic Imagine

K161999Aixplorer 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

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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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