# Noras Mri Products GmbH

- Location (FDA's records): Hoechberg, DE
- FDA decisions: 10 (2008–2024): 10 510(k) clearances
- Product codes: MOS (10)
- 510(k) review time since 2016: median 64 days, against 59 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 18 (2 its own); citations of its devices by later devices: 5 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mri Devices Corp.: 4 (https://510kreport.com/company/mri-devices)
- Siemens Medical Solutions USA, Inc.: 3 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Moras Mri Products GmbH: 2 (https://510kreport.com/company/moras-mri-products)
- Integra LifeSciences Corporation: 1 (https://510kreport.com/company/integra-lifesciences)
- Noras Rontgen-Und Medizintechnik GmbH: 1 (https://510kreport.com/company/noras-rontgen-und-medizintechnik)
- Machnet BV: 1 (https://510kreport.com/company/machnet)
- Siemens Corp.: 1 (https://510kreport.com/company/siemens)
- Philips Medical Systems (Cleveland), Inc.: 1 (https://510kreport.com/company/philips-medical-systems-cleveland)

## Firms that cite its devices most
- Moras Mri Products GmbH: 1 (https://510kreport.com/company/moras-mri-products)
- Qfix: 1 (https://510kreport.com/company/qfix)
- Noras Rontgen-Und Medizintechnik GmbH: 1 (https://510kreport.com/company/noras-rontgen-und-medizintechnik)

## Its most-cited devices
- K091546: Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230 (2009), cited by 1
- K133506: Noras or Head Holder Flexibility (2014), cited by 1
- K082373: Noras MR-BI320-PA 3T (2008), cited by 1
- K180123: Breast BI 7 MR Coil 1.5T Mammavention (2018), cited by 1
- K083578: Noras CPC Multifunctional Coil (2009), cited by 1

## Recent decisions
- K241069: iLoop Interventional Coil 0.55T (Jun 7, 2024)
- K220144: Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T (Apr 8, 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 (Mar 3, 2022)
- K180123: Breast BI 7 MR Coil 1.5T Mammavention (Feb 16, 2018)
- K133506: Noras or Head Holder Flexibility (Aug 6, 2014)
- K093693: Noras or Head Holder S17000-MQ/ Noras or Head Coil 3T 7230-PH Model S1700-MQ/ 7230-PH (Jan 19, 2010)
- K091546: Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230 (Jun 24, 2009)
- K083578: Noras CPC Multifunctional Coil (Jan 16, 2009)

Source page: https://510kreport.com/company/noras-mri-products