Cleared Traditional

AIXPLORER (K132171) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132171 · Supersonic Imagine · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
71d
Days
Class 2
Risk

K132171 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 Cedex, FR). The FDA issued a Cleared decision on September 24, 2013 after a review of 71 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

Submission Details

510(k) Number K132171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2013
Decision Date September 24, 2013
Days to Decision 71 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
36d faster than avg
Panel avg: 107d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 633
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K132171.
SITE-RITE VISION II ULTRASOUND SYSTEM
K132942 · C.R. Bard, Inc. · Oct 2013
ACUSON S2000 AND S3000
K130881 · Siemens Medical Solutions USA, Inc. · Oct 2013
VOLUSON I/E
K131937 · Ge Healthcare · Sep 2013
LOGIQ S8
K131527 · Ge Healthcare · Aug 2013
DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS
K132341 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2013
DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K130833 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2013