AMRA MEDICAL AB

FDA Device Registration & Listing · Linkoping Ostergotland, SE · Registration 3021593788

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
3021593788
FEI Number
3021593788
Entity Name
AMRA MEDICAL AB
City/State/Country
Linkoping Ostergotland, SE
Establishment Address
Badhusgatan 5, Linkoping Ostergotland 58222, SE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AMRA Medical AB (Owner Number: 10084178)
Owner / Operator Contact Address
Badhusgatan 5, Linköping, SE-E 58222, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K211983
PMA Number
N/A

All Registered Proprietary Names

AMRA Profiler

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 2022-01-24

Official Correspondent

No official correspondent registered.

US Agent Details

Benzy Arazy Business: Medes USA C/O Matan Arazy Email: Medes@Arazygroup.com Phone: (415) 9921126

Related Public Records

Same Entity

AMRA Medical 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 3021593788. Last updated year: 2026. Please use registration number 3021593788 when referencing this establishment in official correspondence.
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