# K133189: Dual Shot Alpha 7

- Pathway: 510(k) (Special)
- Applicant: Nemoto Kyorindo Co., Ltd.
- Decided: Jun 30, 2014 after 256 days
- Product code: DXT (Injector And Syringe, Angiographic)
- 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: 6 generations back to K934086 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062168: Contrast Delivery System - Dual Shot Alpha, Nemoto Kyorindo Co., Ltd. (2006) Summary page 1.
- K071691: Dual Shot Alpha, Nemoto Kyorindo Co., Ltd. (2007) Summary page 1.

## Most influential descendants
- K173450: PRESS DUO elite, PRESS DUO elite AG (2018), 0 descendants of its own

## Indications for use
The DUAL SHOT alpha7 is an intravascular injection system intended for the administration of ionic and non-ionic contrast media and saline used in conjunction with computed X-ray tomography (CT).

Source page: https://510kreport.com/device/K133189
Methodology: https://510kreport.com/methodology