# K123068: Optima MR 430S

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, LLC
- Decided: Nov 13, 2012 after 43 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K971684 (1997). 14 ancestors in all.
No later device cites it as a predicate yet.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103238: 1.5T Optima MR430S, Ge Medical Systems, LLC (2011) Summary page 1.

## Recalls of this device
- Dec 23, 2021 · Class II · Z-0620-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- May 9, 2016 · Class II · Z-1928-2016: The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause crit

## Indications for use
The Optima MR43Os MR Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.

Source page: https://510kreport.com/device/K123068
Methodology: https://510kreport.com/methodology