ESAOTE S.P.A.

FDA Device Registration & Listing · FLORENCE Firenze, IT · Registration 9611125

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9611125
FEI Number
3002806925
Entity Name
ESAOTE S.P.A.
City/State/Country
FLORENCE Firenze, IT
Establishment Address
VIA DI CACIOLLE 15, FLORENCE Firenze 50127, IT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ESAOTE S.P.A. (Owner Number: 8021005)
Owner / Operator Contact Address
via Enrico Melen 77, Genoa, IT-GE 16152, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K161359
PMA Number
N/A

All Registered Proprietary Names

MyLabClass C 6250 MyLabTwice 6200 MyLabEight MyLabEight eXP MyLab 9 eXP 6440 Ultrasound System MyLab 9 MyLabX9 6450 Model MyLabX8 eXP MyLabX8 6400 Model MyLabX7 MyLabX6 6430 US System MyLabX75 MyLabC25 MyLabC30 MyLabOmega 7400 model MyLabOmega eXP MyLabSeven 7400 MyLabAlpha 6400 MylabGamma 7410

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-03-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2017-03-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-03-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-01-15
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-01-15
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-01-15
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-12-19
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-12-19
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-12-19
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-05-13
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-05-13
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-05-13
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-09-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-09-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-09-17
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-12-05
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-12-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-12-05
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-12-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-04-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-04-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-04-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-11-09
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-11-09
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-11-09

Official Correspondent

Esaote Regulatory

US Agent Details

Kim Akers Business: Esaote North America, Inc Email: kim.akers@esaote.com Phone: (317) 8136013

Related Public Records

Same Entity

ESAOTE S.P.A.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013839079 EBIT S.r.l. Genova, IT
8043485 ESAOTE S.P.A. GENOVA Liguria, IT
3012981490 ESAOTE S.P.A. Sesto Fiorentino Firenze, IT
1826555 Esaote North America, Inc Fishers, IN, US
3012987001 Proton B.V. GM Sittard Limburg, NL

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K882805 Coopervision-Cilco CILCO VILLASENOR PACHYMETER 1988-08-12
K791040 Shimadzu Corp. SECTOR SCANNER, SDU-100, COMPUTERIZED 1979-10-04
K162372 Qt Ultrasound, LLC QT Ultrasound Breast Scanner-1 2017-06-06
K930964 Acuson Corp. ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) 1994-10-26
K052355 U-Systems, Inc. AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS 2005-09-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2011 Verathon, Inc. 2
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011 Verathon, Inc. 2
AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011 Verathon, Inc. 2
BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014 SonoSite, Inc. 2
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611125. Last updated year: 2026. Please use registration number 9611125 when referencing this establishment in official correspondence.
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