# K093348: 3.0T 16 Channel Head Neck Spine Coil

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Coils (Usa Instruments, Inc.)
- Decided: Nov 25, 2009 after 29 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 K001870 (2000). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052916: Usa Instruments 3.0T Brain/Spine Array, Usa Instruments, Inc. (2005) Summary page 2.

## Cited in the summary but kept off the family tree
- K052612: Disposable Powder Free Vinyl Exam Gloves with Vitamin Complex, Nopal and Lanolin Blue Color, Shanghai Antares Industries, Inc. (2005). Our reading of the summary gave K052612, FDA’s number for Disposable Powder Free Vinyl Exam Gloves with Vitamin… (Shanghai Antares Industries, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “1.5T 16 Channel Brain/Spine Coil”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K113365: Infant Array (2012), 2 descendants of its own
- K140998: Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim Coil (2014), 1 descendant 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 GE 3.OT 16 Channel Head Neck Spine Coil is a receive-only RF coil designed for use with the 3.OT MIR system manufactured by GE Healthcare. The coil is intended for imaging of the brain; cervical, thoracic and lumbar spines; as well as the soft tissues and vasculature of the head, neck, and upper chest. The nucleus excited is hydrogen.

Source page: https://510kreport.com/device/K093348
Methodology: https://510kreport.com/methodology