Cleared Traditional

K161999 - Aixplorer

K161999 is an FDA 510(k) clearance for Aixplorer, 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 119-day FDA review.

K161999 · Supersonic Imagine · Radiology device
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Nov 2016
Decision
119d
Days
Class 2
Risk

K161999 is an FDA 510(k) clearance for the Aixplorer. 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 November 16, 2016 after a review of 119 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 - K161999

510(k) Number K161999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2016
Decision Date November 16, 2016
Days to Decision 119 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 107d · This submission: 119d
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 874
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