# K152469: ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions, Inc., Ultrasound Division
- Decided: Sep 21, 2015 after 21 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: 19 generations back to K935595 (1995). 176 ancestors in all.
33 later devices descend from it; 2 cite it directly.
0 of 210 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 7.
- K121699: Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2012) Summary page 11.

## Most influential descendants
- K161787: ACUSON NX2 Diagnostic Ultrasound Systems (2016), 30 descendants of its own
- 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

## Recalls of this device
- Jan 28, 2019 · Class II · Z-2353-2019: 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-2352-2019: 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
For ACUSON NX3 The ACUSON NX3 ultrasound imaging system, is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts(Small Organ), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology 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. For ACUSON NX3 Elite ACUSON NX3 Elite ultrasound imaging systems are intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts(Small Organ including intra-operative), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology 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 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/K152469
Methodology: https://510kreport.com/methodology