Cleared Traditional

K132466 - MYLABSEVEN 6400

K132466 is the FDA 510(k) clearance for MYLABSEVEN 6400 by Esaote, S.P.A.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K132466 · Esaote, S.P.A. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
119d
Days
Class 2
Risk

K132466 is an FDA 510(k) clearance for the MYLABSEVEN 6400, MYLABALPHA 7400. 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 Esaote, S.P.A. (Indianpolis, US). The FDA issued a Cleared decision on December 4, 2013 after a review of 119 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 Esaote, S.P.A. devices

Submission Details

510(k) Number K132466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2013
Decision Date December 04, 2013
Days to Decision 119 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
12d slower than avg
Panel avg: 107d · This submission: 119d
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 789
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K132466.
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
K133505 · Samsung Medison Co., Ltd. · Dec 2013
ACUSON
K131164 · Siemens Medical Solutions USA, Inc. · Dec 2013
VENUE 50
K133431 · Ge Healthcare · Dec 2013
MYLABSEVEN, MYLABALPHA
K132231 · Esaote, S.P.A. · Nov 2013
UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM
K133329 · Samsung Medison Co., Ltd. · Nov 2013
DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM
K132779 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2013