# K080048: MSK Extreme MR Scanner, Model AA5000

- Pathway: 510(k) (Special)
- Applicant: Oni Medical Systems, Inc.
- Decided: Feb 6, 2008 after 29 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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: 4 generations back to K971684 (1997). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001773: Orthone, Oni, Inc. (2000) Summary page 1.
- K052013: Achieva 1.5T & Inera 1.5T Family, Philips Medical Systems Nederland B.V. (2005) Summary page 1.
- K052164: Magnetom Systems with Software Syngo MR 2006A, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.

## Most influential descendants
- K103238: 1.5T Optima MR430S (2011), 1 descendant of its own
- K123068: Optima MR 430S (2012), 0 descendants of its own

## Recalls of this device
- May 9, 2016 · Class II · Z-1927-2016: 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
- Mar 28, 2013 · Class II · Z-1211-2013: Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
- Aug 29, 2011 · Not classified · Z-0107-2012: GE Healthcare has recently become aware that an exposed high voltage gradient wire internal to the MSK 1.5T Extreme system equipment may cause electrical shock, which may impact service personnel safe

## Indications for use
The ONI MSK ExtremeTM 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/K080048
Methodology: https://510kreport.com/methodology