# K241069: iLoop Interventional Coil 0.55T

- Pathway: 510(k) (Abbreviated)
- Applicant: Noras Mri Products GmbH
- Decided: Jun 7, 2024 after 49 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: 18 generations back to K971684 (1997). 40 ancestors in all.
No later device cites it as a predicate yet.
8 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203443: MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea, Siemens Medical Solutions USA, Inc. (2021) Summary page 4.

## Indications for use
The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in a magnetic resonance tomograph, the iLoop Interventional Coil 0.55T is intended to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. This device may be used for interventional procedures.

Source page: https://510kreport.com/device/K241069
Methodology: https://510kreport.com/methodology