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NORAS MRI products GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30049293073004929307NORAS MRI products GMBH1N2027-01-01LEIBNIZSTRASSE 4 HOECHBERG Bavaria DE 97204

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04251269207297iLoop Interventional Coil 0.55T - The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in a magnetic resonance tomograph, the iLoop Interventional Coil 0.55T is intended to produce transversal, sagittal, coronal and oblique images of the internal structures of the body.+49931299270sales@noras.de
04251269207334Breast BI 7 MR Coil Set 1.5T - The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.The included Breast Biopsy Unit permits MR guided breast biopsy and placement of localization-wire by a trained physician.+49931299270sales@noras.de
04251269207341Breast BI 7 MR Coil Set 1.5T - The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.The included Breast Biopsy Unit permits MR guided breast biopsy and placement of localization-wire by a trained physician.+49931299270sales@noras.de

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
649421042966011K241069iLoop Interventional Coil 0.55TMOS2024-06-07
649421462676864K220144Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3TMOS2022-04-08
649421982764502K211658OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3TMOS2022-03-03
649421770410398K190668Encompass 15 Channel Head Coil, 3TMOS2019-09-09
649421456605234K180123Breast BI 7 MR Coil 1.5T MammaventionMOS2018-02-16
649422049111183K162651Breast BI 7 MR Coil Mammavention 3TMOS2017-01-18
649421407218705K14025216 CH MULTIPURPOSE COIL VARIETYMOS2014-05-08
649421686578182K133506NORAS OR HEAD HOLDER FLEXIBILITYMOS2014-08-06
649421286961190K093693NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PHMOS2010-01-19
649421261613467K091546NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230MOS2009-06-24
649421665734866K082373NORAS MR-BI320-PA 3TMOS2008-08-29
649421901910954K081118NORAS MR-BI320-PA 1.5TMOS2008-05-02
649421149466800K071179NORAS OR HEAD HOLDERMOS2007-06-13
649421812636621K060758OR HEAD COIL 1.5 TMOS2006-05-05
649421899006425K052987BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CCLNH2005-11-08
649421621446369K010570BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160LNH2001-04-09
649421888865912

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MOS142024-06-07
LNH22005-11-08

PMN#

GUDID#

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