# K132444: Atama System

- Pathway: 510(k) (Traditional)
- Applicant: Monteris Medical,
- Decided: Jan 27, 2014 after 174 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 K013159 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110411: Atama System, Monteris Medical, Inc. (2011) Summary page 1.

## Indications for use
The intended use of the AtamATM 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-operative 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/K132444
Methodology: https://510kreport.com/methodology