Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10

K-Number: K180572 · 2018-05-29

ApplicantSupersonic Imagine
Decision Date2018-05-29
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 is a medical device manufactured by Supersonic Imagine. It received FDA 510(k) clearance on 2018-05-29 under approval number K180572. 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 MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10?

AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 is a medical device that received FDA 510(k) clearance on 2018-05-29. It is manufactured by Supersonic Imagine. The 510(k) number is K180572.

When was AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 approved by the FDA?

AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 received FDA 510(k) clearance on 2018-05-29, under approval number K180572.

What company makes AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10?

AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 is manufactured by Supersonic Imagine.

What is the FDA product code for AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10?

The FDA product code for AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 is IYN.

Related Clinical Trials

NCT07040696 Accuracy of Venous Excess Ultrasound Score at Hospital Admission to Predict Acute Kidney Injury COMPLETED NCT05857852 Low-Intensity Focused Ultrasound for Cocaine Use Disorder COMPLETED NCT07385508 Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches RECRUITING NCT07234188 POM vs HFNC for Hypoxemia Prevention in Children COMPLETED NCT04896476 Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae COMPLETED NCT07590063 Technology Development of Diagnostic Ultrasound System for Obstetric Imaging NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42207283 [Legal responsibility in AI-assisted radiological reporting]. Radiologie (Heidelberg, Germany) (2026) PMID: 42037982 Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan. Digital health (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41513582 Medical devices for professional use: What assessment, what funding? Therapie (2026)

Other Devices by Supersonic Imagine

K161999Aixplorer K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems 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.

↑