Data / Medical devices / Germany / NORAS MRI products GMBH
NORAS MRI products GMBH: FDA-registered device maker in HOECHBERG Bavaria, Germany, 16 510(k) clearances
NORAS MRI products GMBH is registered with the FDA (registration 3004929307) in HOECHBERG Bavaria, Germany. It lists 4 device types. The FDA files 16 510(k) clearances under its listings, the newest dated June 7, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004929307
- Address
- Leibnizstrasse 4, HOECHBERG Bavaria, Germany, 97204
- Owner or operator
- NORAS MRI products GmbH (9071737)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 9, 2007
- Registered through
- 2026
- Brand names listed
- 4 Ch BI Breast MR Coil Kit 1.5T, 4 Ch BI Breast MR Coil Kit 3T, BI160-CC, BI160-O, BI160-PA, Breast BI 7 MR Coil 1,5T, Breast BI 7 MR Coil Mammavention 3T, Breast BI 7 MR Coil Set 1.5T and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Head, Neurosurgical (Skull Clamp) | HBL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 7, 2024 | K241069 | iLoop Interventional Coil 0.55T | MOS | Substantially Equivalent | Noras Mri Products GmbH | accessdata.fda.gov |
| April 8, 2022 | K220144 | Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T | MOS | Substantially Equivalent | Noras Mri Products GmbH | accessdata.fda.gov |
| March 3, 2022 | K211658 | OR 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 3T | MOS | Substantially Equivalent | Noras Mri Products GmbH | accessdata.fda.gov |
| September 9, 2019 | K190668 | Encompass 15 Channel Head Coil, 3T | MOS | Substantially Equivalent | Qfix | accessdata.fda.gov |
| February 16, 2018 | K180123 | Breast BI 7 MR Coil 1.5T Mammavention | MOS | Substantially Equivalent | Noras Mri Products GmbH | accessdata.fda.gov |
| January 18, 2017 | K162651 | Breast BI 7 MR Coil Mammavention 3T | MOS | Substantially Equivalent | Moras Mri Products GmbH | accessdata.fda.gov |
| August 6, 2014 | K133506 | NORAS OR HEAD HOLDER FLEXIBILITY | MOS | Substantially Equivalent | Noras Mri Products GmbH | accessdata.fda.gov |
| May 8, 2014 | K140252 | 16 CH MULTIPURPOSE COIL VARIETY | MOS | Substantially Equivalent | Noras Rontgen-Und Medizintechnik GmbH | accessdata.fda.gov |
| January 19, 2010 | K093693 | NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH | MOS | Substantially Equivalent | Noras Mri Products GmbH | accessdata.fda.gov |
| June 24, 2009 | K091546 | NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 | MOS | Substantially Equivalent | Noras Mri Products GmbH | accessdata.fda.gov |
| August 29, 2008 | K082373 | NORAS MR-BI320-PA 3T | MOS | Substantially Equivalent | Noras Mri Products GmbH | accessdata.fda.gov |
| May 2, 2008 | K081118 | NORAS MR-BI320-PA 1.5T | MOS | Substantially Equivalent | Noras Mri Products GmbH | accessdata.fda.gov |
| June 13, 2007 | K071179 | NORAS OR HEAD HOLDER | MOS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 5, 2006 | K060758 | OR HEAD COIL 1.5 T | MOS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 8, 2005 | K052987 | BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC | LNH | Substantially Equivalent | Noras Rontgen-Und Medizintechnik GmbH | accessdata.fda.gov |
| April 9, 2001 | K010570 | BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160 | LNH | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Holder, Head, Neurosurgical (Skull Clamp)
- All makers of Guide, Needle, Surgical
Updated June 7, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.