# K133986: 1.5T Orbit and Mandible Array, 3.0T Orbit and Mandible Array

- Pathway: 510(k) (Traditional)
- Applicant: Resonance Innovations, LLC
- Decided: Jan 27, 2014 after 32 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K183186: Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 (2019), 0 descendants of its own

## Indications for use
The Indications for use are as follows: The family is to be used in conjunction with a GE 1.5T and GE 3.0T Magnetic Resonance Scanner, to produce diagnostic images of the orbits and surrounding anatomy, as well as mandible regions that can be interpreted by a trained physician. The intended use for the device family is to provide MRI antenna sets to facilitate targeting imaging of the orbit region and mandible region. Tissue of the brain and face with emphasis on the orbits, and of the mandible joint of the head.

Source page: https://510kreport.com/device/K133986
Methodology: https://510kreport.com/methodology