# K162722: HyperSense

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Apr 20, 2017 after 203 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: 13 generations back to K971684 (1997). 30 ancestors in all.
No later device cites it as a predicate yet.
5 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142085: Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5T, Ge Medical Systems, LLC (2014) Summary page 4.

## Indications for use
HyperSense is a software feature intended for use on GE MR 1.5T and 3.0T Systems. HyperSense is an acceleration technique based on sparse data sampling and iterative reconstruction that allows users to reduce scan times or increase scan resolution. HyperSense can be used for non-contrast enhanced imaging of the head, neck, spine, extremities, pelvis, and abdomen.

Source page: https://510kreport.com/device/K162722
Methodology: https://510kreport.com/methodology