# K041185: Torso Array Coil, Model 558GE-64

- Pathway: 510(k) (Traditional)
- Applicant: Igc-Medical Advances, Inc.
- Decided: May 14, 2004 after 8 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.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hitachi AIRIS-Elite 0.3T system: named in the summary without a submission number

## Most influential descendants
- K063513: Echelon MR-RCC-150 Cardiac Coil (2006), 8 descendants of its own
- K081340: Pediatric Body and Cardiac Coil, Model 01000140201 (2008), 6 descendants of its own
- K101949: Pediatric Body-Cardiac Coil, Model: 5000012601 (2010), 5 descendants of its own
- K213397: InkSpace Imaging Pediatric Body Array (2021), 4 descendants of its own
- K223487: InkSpace Imaging Body Array (2022), 3 descendants of its own

## Indications for use
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures of the torso, pelvis, and abdomen.

Source page: https://510kreport.com/device/K041185
Methodology: https://510kreport.com/methodology