SYNTHETICMR AB

FDA Device Registration & Listing · Linkoping Ostergotland, SE · Registration 3014111222

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
3014111222
FEI Number
3014111222
Entity Name
SYNTHETICMR AB
City/State/Country
Linkoping Ostergotland, SE
Establishment Address
Storgatan 11, Linkoping Ostergotland SE-582 23, SE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SyntheticMR AB (Owner Number: 10056087)
Owner / Operator Contact Address
Storgatan 11, Linkoping, SE-NOTA SE-582 23, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233733
PMA Number
N/A

All Registered Proprietary Names

SyMRI SyMRI SyMRI SyMRI SyMRI SyMRI SyMRI

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 2020-08-03
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-06-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-08-07
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2021-12-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2017-11-05
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-01-29
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-01-29
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-11-07

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

SyntheticMR AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014111222. Last updated year: 2026. Please use registration number 3014111222 when referencing this establishment in official correspondence.
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