# K013159: HRH-63-8 Head Array Coil

- Pathway: 510(k) (Special)
- Applicant: Mri Devices Corp.
- Decided: Oct 16, 2001 after 25 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
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022669: 8 Channel Cardiac Phased Array Coil (2002), 5 descendants of its own
- K060758: OR Head Coil 1.5 T (2006), 4 descendants of its own
- K031209: GE 1.5T 8 Channel Torso Coil (2003), 3 descendants of its own
- K110411: Atama System (2011), 1 descendant of its own
- K091546: Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230 (2009), 1 descendant of its own

## Indications for use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head, that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K013159
Methodology: https://510kreport.com/methodology