# K033753: Pelvic Array Coil

- Pathway: 510(k) (Special)
- Applicant: Usa Instruments, Inc.
- Decided: Dec 17, 2003 after 16 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: 4 generations back to K893619 (1989). 15 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001209: Insight Plus 9000 Phased Array Torso and Pelvis Coil, Usa Instruments, Inc. (2000)
- K013854: Mark 5000 Quadrature Shoulder Coil, Usa Instruments, Inc. (2002)

## Most influential descendants
- K061715: Mrgfus General Purpose and Breast Coil (2006), 2 descendants of its own
- K083434: TT1 General Purpose Coil (2008), 1 descendant of its own
- K113280: Carotid Coil GE 1.5T (2011), 0 descendants of its own
- K071966: 1.5T Mrgfus Pelvic Coil (2007), 0 descendants of its own

## Indications for use
The Pelvic Array Coil is designed to provide Magnetic Resonance Images of the pelvis, including the hips. The Pelvic Array Coil is designed for use with the GE Signa 1.5T MR scanner. Anatomic Regions: pelvis, including the hips Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Signa 1.5T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Source page: https://510kreport.com/device/K033753
Methodology: https://510kreport.com/methodology