# 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

- Pathway: 510(k) (Traditional)
- Applicant: Noras Mri Products GmbH
- Decided: Mar 3, 2022 after 279 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K050319 (2005). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133506: Noras or Head Holder Flexibility, Noras Mri Products GmbH (2014) Summary page 7.
- K130389: Mayfield Infinity XR2 Skull Clamp, Integra LifeSciences Corporation (2013) Summary page 7.

## Indications for use
The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scanner, intra-operative MR imaging during an open-skull neurosurgery. The OR Head Holder LUCY is used for safe securing the patient's head during a surgical intervention at the head. It is possible to make an intraoperative assessment during the intervention to determine its progress. In the MR area the Head Coils enable the diagnostic imaging. Using Computed Tomography or C-arm Fluoroscopy, it is mandatory to remove the Head Coils and the device serves as a skull clamp only.

Source page: https://510kreport.com/device/K211658
Methodology: https://510kreport.com/methodology