# K050237: Starshield V3 RF TRNT

- Pathway: 510(k) (Special)
- Applicant: Odin Medical Technologies, Ltd.
- Decided: Mar 18, 2005 after 44 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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: 2 generations back to K002242 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022157: RF Tent, Odin Medical Technologies, Ltd. (2002) Summary page 2.

## Indications for use
The PoleStar system is a magnetic resonance diagnostic device intended for general diagnostic use to present images, which reflect the spatial distribution and/or magnetic resonance spectra, which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. The StarShield V3 is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent during image acquisition by the PoleStar system.

Source page: https://510kreport.com/device/K050237
Methodology: https://510kreport.com/methodology