# K071179: Noras or Head Holder

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 13, 2007 after 47 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: 1 generation back to K012495 (2001). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012495: OR Table and Headholder/Magnetom Harmony, Symphony, Sonata Systems, Siemens Medical Solutions USA, Inc. (2001) Summary page 4.

## Most influential descendants
- K133506: Noras or Head Holder Flexibility (2014), 1 descendant of its own
- K110411: Atama System (2011), 1 descendant of its own
- K091439: Head Fixation Arc and Table Base (2009), 1 descendant of its own
- 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 (2022), 0 descendants of its own
- K191701: Arcus Head Fixation Frame (2019), 0 descendants of its own

## Indications for use
The intended use of the Noras OR Head Holder, in conjunction with a Magnetic Resonance Scanner, is to stabilize patient's head during neurosurgical procedures, Used in conjunction with Siemens MAGNETOM Systems and the Noras OR Head Coil, it is indicated for use together with a navigation system. Special Accessories are available for use with the head holder for awake craniotomies, pediatric patients and minimally invasive interventions.

Source page: https://510kreport.com/device/K071179
Methodology: https://510kreport.com/methodology