Cleared Abbreviated

SONIC WINDOW (K140126) - FDA 510(k) Clearance

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

K140126 · Analogic Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
47d
Days
Class 2
Risk

K140126 is an FDA 510(k) clearance for the SONIC WINDOW. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Analogic Corporation (Peabody, US). The FDA issued a Cleared decision on March 4, 2014 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Analogic Corporation devices

Submission Details

510(k) Number K140126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2014
Decision Date March 04, 2014
Days to Decision 47 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 107d · This submission: 47d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 217
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K140126.
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
K150529 · C.R. Bard, Inc. · Mar 2015
Site-Rite 6 Ultrasound System with Pinpoint GT Technology
K142443 · C.R. Bard, Inc. · Oct 2014
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
K142395 · Siemens Medical Solutions USA, Inc. · Sep 2014
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K131690 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2013
ILAB ULTRASOUND IMAGING SYSTEM
K130243 · Boston Scientific Corp · Mar 2013
ILAB ULTRASOUND IMAGING SYSTEM
K123535 · Boston Scientific Corp · Jan 2013