# K060689: 1.5T Pediatric Head and Spine Array Model

- Pathway: 510(k) (Special)
- Applicant: Resonance Innovations, LLC
- Decided: Mar 31, 2006 after 16 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 K951649 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951649: Model #801GE1500 Pediatric Array Coil, Medic, Inc. (1995) Summary page 1.

## Indications for use
Soft tissue and bone imaging of the spine and brain as allowed by the MRI system. Magnetic resonance angiography.

Source page: https://510kreport.com/device/K060689
Methodology: https://510kreport.com/methodology