# K091734: Sonic Shot GX

- Pathway: 510(k) (Traditional)
- Applicant: Nemoto Kyorindo Co., Ltd.
- Decided: May 21, 2010 after 344 days
- Product code: IZQ (Injector, Contrast Medium, Automatic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- 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 K012950 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984088: Optistar MR Injector System, Mallinckrodt Inc., Liebel-Flarsheim Business (1999) Summary page 1.
- K042784: Medrad Spectris Solaris EP MR Injector System, Medrad, Inc. (2004) Summary page 1.

## Indications for use
The contrast delivery system Sonic Shot GX is an intravascular injection system intended for the administration of MRI contrast media and normal saline solution used in conjunction with magnetic resonance imaging (MRI).

Source page: https://510kreport.com/device/K091734
Methodology: https://510kreport.com/methodology