Cleared Traditional

K222191 - Aixplorer MACH30 / SUPERSONIC MACH30

K222191 is an FDA 510(k) clearance for Aixplorer MACH30 / SUPERSONIC MACH30, manufactured by Supersonic Imagine. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K222191 · Supersonic Imagine · Radiology device
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Oct 2022
Decision
98d
Days
Class 2
Risk

K222191 is an FDA 510(k) clearance for the Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20,.... Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Supersonic Imagine (Aix En Provence, FR). The FDA issued a Cleared decision on October 28, 2022 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Supersonic Imagine devices

FDA 510(k) Submission Details - K222191

510(k) Number K222191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2022
Decision Date October 28, 2022
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 872
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K222191.
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
K220983 · Imsonic Medical China, Inc. · Nov 2022
Exo Iris (El2001)
K222198 · Exo Imaging, Inc. · Nov 2022
ViewMate Multi Ultrasound System
K222754 · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Nov 2022
Leltek Ultrasound Imaging System (Model: LU700 Series)
K222365 · Leltek, Inc. · Oct 2022
X-CUBE 70, X-CUBE 90
K221093 · Alpinion Medical Systems Co., Ltd. · Oct 2022
Wireless Probe Type Ultrasound Scanner (Model: CProbe
K211321 · Guangzhou Sonostar Technologies Co., Ltd. · Oct 2022