Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043485

FEI Number

3002806926

Entity Name

ESAOTE S.P.A.

City/State/Country

GENOVA Liguria, IT

Establishment Address

Via Multedo di Pegli 2/E, GENOVA Liguria 16155, 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

Expiration Date (Year)

2026

510(k) Number

K251901

PMA Number

N/A

All Registered Proprietary Names

G-Scan Brio G-Scan Open OrthoCAD G-scan Brio Shoulder Coil 20 S-scan Head Coil 16 S-Scan Open Magnifico MSK Magnifico Open MRI Dynamic Analysis Plus Magnifico Open

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-12-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-01-24
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2016-11-09
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-07-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2016-03-16
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2026-03-12

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
3012981490	ESAOTE S.P.A.	Sesto Fiorentino Firenze, 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
K033504	General Electric Co.	GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM	2003-11-25
K013636	GE Medical Systems	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	2002-01-24
K250443	Siemens Healthcare GmbH	MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile	2025-06-16
K151015	Hitachi Medical Systems America, Inc.	ECHELON Oval V 5.0 MRI System	2015-07-29
K910715	Philips Medical Systems (Cleveland), Inc.	VISTA HPQ SYSTEM	1991-06-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2007	Hitachi Medical Systems America Inc	2	MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014	Philips Medical Systems (Cleveland) Inc	2	Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024	Philips North America Llc	2	Achieva 1.5T
Z-0390-2024	Philips North America Llc	2	Achieva 1.5T Conversion
Z-0391-2024	Philips North America Llc	2	Achieva 1.5T Initial System

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3033536331	NEOSCAN SOLUTIONS GMBH	Magdeburg Saxony-Anhalt, DE
3020162557	SPINTECH, INC.	Bingham Farms, MI, US
3012354318	JIANGSU MAGSPIN INSTRUMENT CO., LTD	Kunshan Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043485. Last updated year: 2026. Please use registration number 8043485 when referencing this establishment in official correspondence.