# K033292: Airis-Elite Rapid Body Coil, Model 554HI-12

- Pathway: 510(k) (Traditional)
- Applicant: Igc-Medical Advances, Inc.
- Decided: Nov 26, 2003 after 43 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 its predicate without a number.
- (no number) GE Signa 0.5T system: named in the summary without a submission number
- (no number) GE Signa 1.5T system: named in the summary without a submission number

## Indications for use
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.

Source page: https://510kreport.com/device/K033292
Methodology: https://510kreport.com/methodology