Cleared Traditional

K133761 - APLIO 500/400/300 DIAGNOSTIC ULTRASOUND...

K133761 is the FDA 510(k) clearance for APLIO 500/400/300 DIAGNOSTIC ULTRASOUND... by Toshibamedical Systems Corporation. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K133761 · Toshibamedical Systems Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
132d
Days
Class 2
Risk

K133761 is an FDA 510(k) clearance for the APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0. 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 Toshibamedical Systems Corporation (Tustin, US). The FDA issued a Cleared decision on April 22, 2014 after a review of 132 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Toshibamedical Systems Corporation devices

Submission Details

510(k) Number K133761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2013
Decision Date April 22, 2014
Days to Decision 132 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 107d · This submission: 132d
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 786
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K133761.
M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM
K141010 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2014
ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
K140959 · Siemens Medical Solutions USA, Inc. · Apr 2014
MYLABSSOGNO
K140677 · Esaote, S.P.A. · Apr 2014
6200 / 6250 ULTRASOUND SYSTEM
K133905 · Esaote, S.P.A. · Apr 2014
DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM
K140030 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2014
LOGIQ E
K133533 · Ge Healthcare · Feb 2014