# K111060: Mrgfus Pelvic PA Coil Model 1.0

- Pathway: 510(k) (Special)
- Applicant: Insightech, Ltd.
- Decided: Sep 9, 2011 after 144 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The MRgFUS Phase Array Pelvic Coil (the MRgFUS PA Coil) is a receive only RF coil, designed for MR imaging of the pelvis and hips. The MRgFUS Coil is designed for use with the GE 1.5 T MRI systems manufactured by GE Medical Systems. The Pelvic Phase Array Coil can be used in conjunction with the InSightec Focused UltraSound (MRgFUS) treatment.

Source page: https://510kreport.com/device/K111060
Methodology: https://510kreport.com/methodology