# K120748: Speedup Software Option

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: May 1, 2012 after 50 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 K911667 (1991). 49 ancestors in all.
No later device cites it as a predicate yet.
1 of 50 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111803: G-SCAN, Esaote, S.p.A. (2011)
- K080968: S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera, Esaote, S.p.A. (2008) Summary page 1.
- K092469: O-Scan MR System, Esaote, S.p.A. (2009) Summary page 1.
- K043147: Achieva Family, Philips Medical Systems North America Co. (2005) Summary page 1.

## Indications for use
SpeedUp is an imaging technique to increase scan speed reducing the acquisition time. The sparsity which is implicit in MR images is exploited to significantly undersample the k-space, resulting in incoherent artifacts (noise like). Time is decreased reducing the number of acquired k-space lines (i.e. undersampling) and the final image can be reconstructed accurately with an appropriate non-linear reconstruction method.

Source page: https://510kreport.com/device/K120748
Methodology: https://510kreport.com/methodology