# K030495: 3.0T Torso Phased Array Coil

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Mar 5, 2003 after 14 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 K971667 (1997). 2 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K971667: Cardiac Phased Array Coil, GE Medical Systems (1997) Summary page 1.
- K001209: Insight Plus 9000 Phased Array Torso and Pelvis Coil, Usa Instruments, Inc. (2000) Summary page 1.

## Most influential descendants
- K031209: GE 1.5T 8 Channel Torso Coil (2003), 3 descendants of its own
- K052584: 1.5T 12 Channel Body Array (2005), 1 descendant of its own
- K101492: 8 Channel Cardiac Phased Array Coil (2010), 0 descendants of its own
- K073236: Neocoil 3.0T 32-Channel Torso Array Coil for GE (2007), 0 descendants of its own

## Indications for use
The coil is indicated for use, on the order of a physician in conjunction with a 3.OT MR scanner, as an accessory to produce images of the abdominal and pelvic regions in 2D and 3D. The primary applications associated with evaluation of the anatomy are as follows: Thorax Abdomen Male and Female Pelvis Prostate

Source page: https://510kreport.com/device/K030495
Methodology: https://510kreport.com/methodology