# K192835: ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 22, 2019 after 20 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K935595 (1995). 178 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173957: ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2018) Summary page 5.

## Most influential descendants
- K202683: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic  Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON  NX3, NX3 Elite Diagnostic Ultrasound System (2020), 6 descendants of its own
- K211726: Acuson SC2000 Diagnostic Ultrasound System (2021), 4 descendants of its own
- K242893: VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (2025), 2 descendants of its own
- K261849: VERAFEYE Imaging Catheter (VF-VIC-002) (2026), 0 descendants of its own
- K260885: VERAFEYE Imaging and Guidance System (VF-VIS-002) (2026), 0 descendants of its own

## 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), Neonatal Cephalic, Adult Cephalic, 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. For ACUSON NX3 Elite The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts (Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), 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. 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 should 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/K192835
Methodology: https://510kreport.com/methodology