Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004929307

FEI Number

3004929307

Entity Name

NORAS MRI products GMBH

City/State/Country

HOECHBERG Bavaria, DE

Establishment Address

LEIBNIZSTRASSE 4, HOECHBERG Bavaria 97204, DE

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NORAS MRI products GmbH (Owner Number: 9071737)

Owner / Operator Contact Address

LEIBNIZSTRASSE 4, --, HOECHBERG, DE-NOTA 97204, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K082373

PMA Number

N/A

All Registered Proprietary Names

OR Head Coil 3T 114557 Top Array OR Head Coil 3T 114558 Bottom Array OR Head Coil 1.5T 111921 Top Array OR Head Coil 1.5T 111922 Bottom Array OR Head Holder SI7000-MQ OR Head Holder 113066 OR Head Coil 1.5T 7130-PH OR Head Coil 3T 7230-PH OR HEAD COIL 1.5 T OR Head Coil 1.5T 114491 Bottom Array OR Head Coil 1.5T 114497 Top Array SI7130 Immobilization and Biopsy System for OBC Breast Coil Invivo MR BI160-GE MR BI160 Immobilization and Biopsy System for GE High Density Mamma Coil NORAS OR Head Holder Flexibility 114464 OR Head Holder SI7000 OR Head Holder SI7300 OR Head Holder 113056 iLoop Interventional Coil BI160-O BI160-CC BI160-PA Breast Immobilization and Biopsy Device Breast BI 7 MR Coil 1,5T 4 Ch BI Breast MR Coil Kit 1.5T MR-BI320-PA 1.5T OR Head Coil 3T 113719 Bottom Array OR Head Coil 3T 112893 Top Array SI7230 OR Head Coil 3T 4 Ch BI Breast MR Coil Kit 3T MR-BI320-PA 3T

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2010-02-03
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2007-07-09
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2007-12-21
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2014-12-10
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2014-12-10
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2007-07-09
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2007-07-09
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2024-06-11
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2007-12-21
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2007-12-21
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2019-01-30
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2014-12-10
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2008-09-22
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2010-02-03
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2008-09-22

Official Correspondent

Manuel NORAS

US Agent Details

Alena Newgren Business: MEDTEC LLC Email: regulatory@civcort.com Phone: (319) 2486650

Related Public Records

Same Entity

NORAS MRI products GmbH

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
K121249	Paramed S.R.L.	MULTIARRAY KIT	2012-06-12
K000935	Mri Devices Corp.	KFA-63 KNEE AND FOOT ARRAY	2000-04-07
K102889	Hitachi Medical Systems America, Inc.	HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON	2010-12-20
K110373	Esaote, S.p.A.	TEMPOROMANIBULAR COIL 15	2011-04-06
K030317	Midwest Rf, LLC	MODEL 1300GE-64: PEDIATRIC POSITIONER	2003-03-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2020	Quality Electrodynamics LLC	2	TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Z-0032-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
Z-0033-2020	Quality Electrodynamics LLC	2	TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Z-0034-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
Z-0035-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004929307. Last updated year: 2026. Please use registration number 3004929307 when referencing this establishment in official correspondence.