# K161787: ACUSON NX2 Diagnostic Ultrasound Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 28, 2016 after 29 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K935595 (1995). 177 ancestors in all.
30 later devices descend from it; 2 cite it directly.
0 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141846: Acuson X700 Ultrasound System, Acuson X600 Ultrasound System, Siemens Medical Solutions USA, Inc. (2014) Summary page 12.
- K152469: ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System, Siemens Medical Solutions, Inc., Ultrasound Division (2015) Summary page 5.

## Most influential descendants
- K163396: ACUSON P500 Ultrasound System (2017), 27 descendants of its own
- K180039: ACUSON P600 Diagnostic Ultrasound System (2018), 25 descendants of its own
- K191922: ACUSON P200 Diagnostic Ultrasound System (2019), 23 descendants of its own
- K210743: ACUSON Redwood Diagnostic Ultrasound System (2021), 15 descendants of its own
- K201130: ACUSON Juniper Diagnostic Ultrasound System (2020), 14 descendants of its own

## 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

## Indications for use
The ACUSON NX2TM ultrasound imaging system is intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system. Note: This feature can be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine."

Source page: https://510kreport.com/device/K161787
Methodology: https://510kreport.com/methodology