Cleared Traditional

K112255 - AIXPLORER

K112255 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 389-day FDA review.

K112255 · Supersonic Imagine · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
389d
Days
Class 2
Risk

K112255 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 August 28, 2012 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K112255

510(k) Number K112255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2011
Decision Date August 28, 2012
Days to Decision 389 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
282d slower than avg
Panel avg: 107d · This submission: 389d
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 942
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K112255.
VIAMO SSA-640A V4.0
K122491 · Toshibamedical Systems Corporation · Sep 2012
VOLUSON P6, VOLUSON P8
K122387 · Ge Healthcare · Sep 2012
UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM
K122583 · Samsung Medison Co., Ltd. · Sep 2012
E-CUBE INNO
K121937 · Alpinion Medical Systems Co., Ltd. · Jul 2012
Z6 DIAGNOSTIC ULTRASOUND SYSTEM
K122010 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2012
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM
K121699 · Siemens Medical Solutions USA, Inc. · Jun 2012