# K012495: OR Table and Headholder/Magnetom Harmony, Symphony, Sonata Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 31, 2001 after 89 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) Neuro II: named in the summary without a submission number

## Most influential descendants
- K071179: Noras or Head Holder (2007), 6 descendants of its own
- 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

## Recalls of this device
- Nov 27, 2002 · Not classified · Z-0976-03: OR Table stops during the transfer of the table to the MR system and will not move.

## Indications for use
The MAGNETOM Harmony, Symphony, and Sonata System with the OR Table and Headholder is a whole body scanner. The MAGNETOM Systems with the OR Table and Headholder is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by MAGNETOM Systems with the OR Table and Headholder reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The OR Table with headholder will be an option for intra-operative and interventional procedures.

Source page: https://510kreport.com/device/K012495
Methodology: https://510kreport.com/methodology