# K052621: 1.5T 16 Channel Brain-Spine Array Coil

- Pathway: 510(k) (Special)
- Applicant: Usa Instruments, Inc.
- Decided: Oct 7, 2005 after 14 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001870 (2000). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001870: Millennium 9000 Phased Array Neurovascular Coil, Usa Instruments, Inc. (2000) 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

## Recalls of this device
- Sep 20, 2006 · Not classified · Z-0163-2007: The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized RF burn and/or el

## Indications for use
The 1.5T Brain / Spine Array Coil is designed for use with the Excite 1.5T MRI system manufactured by GE Healthcare. The coil is for imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine. The nucleus excited is hydrogen.

Source page: https://510kreport.com/device/K052621
Methodology: https://510kreport.com/methodology