# K163205: 48CH Head Coil

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Coils (Usa Instruments, Inc.)
- Decided: Jan 12, 2017 after 58 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: 14 generations back to K971684 (1997). 31 ancestors in all.
3 later devices descend from it; 2 cite it directly.
5 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143345: SIGNA Pioneer, Ge Healthcare Japan Corporation (2015) Summary page 4.

## Most influential descendants
- K180666: 48CH Head Coil (2018), 1 descendant of its own
- K253738: 3.0T Air 32CH Hna (2026), 0 descendants of its own
- 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 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.

Source page: https://510kreport.com/device/K163205
Methodology: https://510kreport.com/methodology