Cleared Traditional

6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System

K161359 · Esaote, S.P.A. · Radiology
Jul 2016
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K161359 is an FDA 510(k) clearance for the 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Esaote, S.P.A. (Genova, IT). The FDA issued a Cleared decision on July 19, 2016, 64 days after receiving the submission on May 16, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K161359 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2016
Decision Date July 19, 2016
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

Similar Devices — IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1150
Sonosite iLOOK Ultrasound System
K260595 · FUJIFILM Sonosite, Inc. · Mar 2026
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System
K253049 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2026
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
K253597 · Canon Medical Systems Corporation · Jan 2026
LOGIQ Totus
K253370 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jan 2026
LOGIQ Fortis
K253366 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jan 2026
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System
K252018 · Samsung Medison Co., Ltd. · Jan 2026