Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
K-Number: K191007 · 2019-10-25
Device Summary
Frequently Asked Questions
What is the Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems?
Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Supersonic Imagine. The 510(k) number is K191007.
When did Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems receive FDA 510(k) clearance?
Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems received FDA 510(k) clearance on 2019-10-25, under 510(k) number K191007.
Who is the listed applicant for Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic 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 MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems?
The FDA product code for Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic 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.
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.
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.