The following data is part of a premarket notification filed by Noras Mri Products Gmbh with the FDA for 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.
| Device ID | K211658 |
| 510k Number | K211658 |
| 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 |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | NORAS MRI Products GmbH Leibnizstr. 4 Hoechberg, DE 97204 |
| Contact | Manuel Noras |
| Correspondent | Patricia Kirchner NORAS MRI Products GmbH Leibnizstr. 4 Hoechberg, DE 97204 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-28 |
| Decision Date | 2022-03-03 |