# K162403: HyperBand

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Nov 18, 2016 after 81 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: 3 generations back to K962061 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012970: GE Signa Asset Imaging Option, GE Medical Systems (2001) Summary page 5.

## Indications for use
HyperBand is a software option intended for use on GE MR 1.5T and 3T Systems. HyperBand consists of an acquisition and reconstruction technique allowing simultaneous excitation of multiple slices at multiple locations to accelerate imaging acquisition times or increase slice coverage without increasing scan time. HyperBand is indicated for echo-planar imaging (EPI) of the head and breast. HyperBand is indicated for imaging all patients not otherwise contraindicated for MRI examination.

Source page: https://510kreport.com/device/K162403
Methodology: https://510kreport.com/methodology