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
FDA 510(k) K211658 · Noras Mri Products GmbH
510(k) numberK211658
Submission
- Device name
- 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
- Applicant
- Noras Mri Products GmbH
Hoechberg, DE - Received
- May 28, 2021
- Decision date
- March 3, 2022
- 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 |
| K180123 | Breast BI 7 MR Coil 1.5T MammaventionMOS · Traditional | 02/16/2018SE |
| K133506 | Noras or Head Holder FlexibilityMOS · Traditional | 08/06/2014SE |
| 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 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 cleared by the FDA?
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 (K211658) received a 510(k) decision of Substantially Equivalent on March 3, 2022, 279 days after the submission was received.
What is the product code of K211658?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.