# K071966: 1.5T Mrgfus Pelvic Coil

- Pathway: 510(k) (Traditional)
- Applicant: Insightec-Txsonics, Inc.
- Decided: Sep 5, 2007 after 51 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: 5 generations back to K893619 (1989). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033753: Pelvic Array Coil, Usa Instruments, Inc. (2003) Summary page 2.

## Indications for use
The Pelvic Array Coil is a receive only phased array RF coil used for obtaining diagnostic images of the pelvis, including the hips, in magnetic resonance imaging systems. The Pelvic Array Coil is designed for use with the GE 1.5T MRI systems manufactured by GE Medical Systems. The Pelvic Array Coil can be used in conjunction with the InSightec Focused UltraSound (FUS) treatment.

Source page: https://510kreport.com/device/K071966
Methodology: https://510kreport.com/methodology