Cleared Traditional

K142008 - MYLABSEVEN

K142008 is the FDA 510(k) clearance for MYLABSEVEN by Esaote, S.P.A.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K142008 · Esaote, S.P.A. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
51d
Days
Class 2
Risk

K142008 is an FDA 510(k) clearance for the MYLABSEVEN, MYLABALPHA. 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 September 12, 2014 after a review of 51 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Esaote, S.P.A. devices

Submission Details

510(k) Number K142008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2014
Decision Date September 12, 2014
Days to Decision 51 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
56d faster than avg
Panel avg: 107d · This submission: 51d
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 K142008.
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
K142160 · Ge Healthcare · Oct 2014
Acuson SC2000 Diagnostic Ultrasound System
K142628 · Siemens Medi Cal Solutions, Inc. · Oct 2014
UGEO PT60A Diagnostic Ultrasound System
K142466 · Samsung Medison Co., Ltd. · Oct 2014
MYLABGAMMA
K142077 · Esaote, S.P.A. · Sep 2014
ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM
K141846 · Siemens Medical Solutions USA, Inc. · Aug 2014
LOGIQ V5/LOGIQ V3
K141768 · Ge Healthcare · Aug 2014