# K110411: Atama System

- Pathway: 510(k) (Traditional)
- Applicant: Monteris Medical, Inc.
- Decided: Apr 8, 2011 after 53 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: 2 generations back to K013159 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060758: OR Head Coil 1.5 T, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.
- K071179: Noras or Head Holder, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K071099: Neuro II-SE, Models: or-DR-or, or-MB, Imris, Inc. (2007) Summary page 2.

## Most influential descendants
- K132444: Atama System (2014), 0 descendants of its own

## Indications for use
The intended use of the AtamA T M System (comprised of two major subsystems: a MR head coil apparatus and a patient stabilization apparatus), in conjunction with a magnetic resonance (MR) imaging system, is the collection of MR data and images of the human brain before, during, and at the end of brain surgery, in a standard operating room, diagnostic MR rooms, or in a MR intra-oiperative room, while stabilizing the patient's head during neurosurgical procedures and imaging. The patient head-stabilizing apparatus can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed. The head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Source page: https://510kreport.com/device/K110411
Methodology: https://510kreport.com/methodology