# K173981: ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc. Ultrasound Group
- Decided: Feb 2, 2018 after 35 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K935595 (1995). 184 ancestors in all.
No later device cites it as a predicate yet.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172374: ACUSON NX2 Diagnostic Ultrasound System,  ACUSON NX2 Elite Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2017) Summary page 4.

## Recalls of this device
- Jan 28, 2019 · Class II · Z-2350-2019: The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW D
- Jan 28, 2019 · Class II · Z-2351-2019: The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW D

## Indications for use
Diagnostic imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K173981
Methodology: https://510kreport.com/methodology