Cleared Special

AIXPLORER (K132274) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K132274 · Supersonic Imagine · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
64d
Days
Class 2
Risk

K132274 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 64 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Supersonic Imagine devices

Submission Details

510(k) Number K132274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2013
Decision Date September 24, 2013
Days to Decision 64 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

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 K132274.
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