ESAOTE S.P.A.

FDA Device Registration & Listing · Sesto Fiorentino Firenze, IT · Registration 3012981490

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
3012981490
FEI Number
3012981490
Entity Name
ESAOTE S.P.A.
City/State/Country
Sesto Fiorentino Firenze, IT
Establishment Address
Via degli Olmi 11, Sesto Fiorentino Firenze 50019, 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
K173291
PMA Number
N/A

All Registered Proprietary Names

MyLabE85 MyLabE80 AU6 7348 7410 model MyLabSigma MyLabSigma elite 6400 Model MyLabX7 MyLabX6 MyLabSix CrystaLine 6425 ML30 (7300 & 7340) ML5 MyLab40 Ultrasound System 6420 MyLabSix MyLabOmega 7400 model MyLabOmega eXP MyLabE80 MyLabE85 6450 Model MyLabX8 eXP MyLabX8 MyLab 9 eXP 6440 Ultrasound System MyLab 9 MyLabX9

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-06-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-06-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-06-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-06-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2011-06-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2011-06-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2011-06-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2014-12-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-12-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-12-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-06-11
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-06-11
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-06-11
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 2016-11-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-11-09
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-11-09
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-09-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-09-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-09-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-01-06
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-01-06
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2014-01-06
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-01-06
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-01-06
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2014-01-06
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
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 2026-04-10
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-04-10
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-10
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-10
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
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

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
1826555 Esaote North America, Inc Fishers, IN, US
9611125 ESAOTE S.P.A. FLORENCE Firenze, IT
3012987001 Proton B.V. GM Sittard Limburg, NL

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30
K191007 Supersonic Imagine Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 2019-10-25
K974588 Rimed , Ltd. INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD 1998-08-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022 FujiFilm Healthcare Americas Corporation 2
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024 FUJIFILM Healthcare Americas Corporation 2
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012981490. Last updated year: 2026. Please use registration number 3012981490 when referencing this establishment in official correspondence.
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