Noras or Head Holder Flexibility
FDA 510(k) K133506 · Noras Mri Products GmbH
510(k) numberK133506
Submission
- Device name
- Noras or Head Holder Flexibility
- Applicant
- Noras Mri Products GmbH
Hoechberg, DE - Received
- November 14, 2013
- Decision date
- August 6, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MOS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…MOS · Special | Philips Medical Systems Nederland B.V. | 07/30/2026SE |
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes…MOS · Special | Philips Medical Systems Nederland B.V. | 07/24/2026SE |
| K260947 | 0.55T 12Ch Breast CoilMOS · Special | Neocoil, LLC | 04/23/2026SE |
| K252587 | HD 8Ch Wrist ArrayMOS · Traditional | Shenzhen RF Tech Co., Ltd. | 04/14/2026SE |
| K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive…MOS · Traditional | Shenzhen RF Tech Co., Ltd. | 04/01/2026SE |
| K260519 | Smart Fit TorsoCardiac 1.5TMOS · Special | Philips Healthcare (Suzhou) Co., Ltd. | 03/20/2026SE |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive…MOS · Traditional | Shenzhen RF Tech Co., Ltd. | 02/10/2026SE |
| K253738 | 3.0T Air 32CH HnaMOS · Abbreviated | Ge Healthcare Coils (Usa Instruments, Inc.) | 01/23/2026SE |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TMOS · Special | Philips Medical Systems Nederland B.V. | 01/14/2026SE |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x)MOS · Special | Inkspace Imaging, Inc. | 10/20/2025SE |
More from Inkspace Imaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241069 | iLoop Interventional Coil 0.55TMOS · Abbreviated | 06/07/2024SE |
| K220144 | Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3TMOS · Traditional | 04/08/2022SE |
| K211658 | OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet…MOS · Traditional | 03/03/2022SE |
| K180123 | Breast BI 7 MR Coil 1.5T MammaventionMOS · Traditional | 02/16/2018SE |
| K093693 | Noras or Head Holder S17000-MQ/ Noras or Head Coil 3T 7230-PH Model S1700-MQ/ 7230-PHMOS · Traditional | 01/19/2010SE |
| K091546 | Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230MOS · Special | 06/24/2009SE |
| K083578 | Noras CPC Multifunctional CoilMOS · Abbreviated | 01/16/2009SE |
| K082373 | Noras MR-BI320-PA 3TMOS · Abbreviated | 08/29/2008SE |
| K081118 | Noras MR-BI320-PA 1.5TMOS · Traditional | 05/02/2008SE |
Questions and answers
When was Noras or Head Holder Flexibility cleared by the FDA?
Noras or Head Holder Flexibility (K133506) received a 510(k) decision of Substantially Equivalent on August 6, 2014, 265 days after the submission was received.
What is the product code of K133506?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.