# K103335: Gem Option for 1.5 Mri Systems

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Mar 7, 2011 after 112 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K971684 (1997). 24 ancestors in all.
3 later devices descend from it; 1 cites it directly.
5 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091536: Optima MR450W, Ge Medical Systems, LLC (2009) Summary page 1.

## Most influential descendants
- K123327: 1.5T Gem RT Open Array (2013), 2 descendants of its own
- K143389: 3.0T GEM RT Open Array (2015), 1 descendant of its own
- K213687: 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch (2022), 0 descendants of its own

## Recalls of this device
- Apr 23, 2014 · Class II · Z-1533-2014: GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle re
- Apr 2, 2014 · Class II · Z-1480-2014: Potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections may loosen causing an increase in resistance. The in
- Apr 12, 2012 · Not classified · Z-1492-2012: GE Healthcare is conducting a recall on Optima MR450W with GEM. During scanning of a patient, if an improperly torqued gradient connection exists, it may cause the gradient lead to produce excessive h

## Indications for use
The GEM Option for 1.5T MRI systems is a set of receive-only RF surface coils designed for use with 1.5T MRI systems manufactured by GE Healthcare. The GEM Option for 1.5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging. The nucleus detected is hydrogen.

Source page: https://510kreport.com/device/K103335
Methodology: https://510kreport.com/methodology