Cleared Traditional

K171105 - AIXPLORER & AIXPLORER Ultimate Ultrasou...

K171105 is an FDA 510(k) clearance for AIXPLORER & AIXPLORER Ultimate Ultrasou..., 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 89-day FDA review.

K171105 · Supersonic Imagine · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
89d
Days
Class 2
Risk

K171105 is an FDA 510(k) clearance for the AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems. 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 Cedex, FR). The FDA issued a Cleared decision on July 11, 2017 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Supersonic Imagine devices

FDA 510(k) Submission Details - K171105

510(k) Number K171105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2017
Decision Date July 11, 2017
Days to Decision 89 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
18d faster than avg
Panel avg: 107d · This submission: 89d
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
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K171105.
HS40 Diagnostic Ultrasound System
K172129 · Samsung Medison Co., Ltd. · Aug 2017
P50 Series Digital Color Doppler Ultrasound System
K170999 · Sonoscape Medical Corp. · Jul 2017
P60 Series Digital Color Doppler Ultrasound System
K171000 · Sonoscape Medical Corp. · Jul 2017
M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System
K171034 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2017
Vivid E80, Vivid E90, Vivid E95
K170823 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 2017
SonoSite X-Porte Ultrasound System
K171437 · FUJIFILM Sonosite, Inc. · Jun 2017