# K083114: Acuson P50 Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 31, 2009 after 161 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: 6 generations back to K894632 (1989). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072266: Acuson P50 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.

## Indications for use
The Acuson P50 Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. The system includes the AcuNav 10F and 8F transducers which are intended for intra-cardiac and intra-luminal visualization of the cardiac and great vessel anatomy and physiology as well as the visualization of other devices in the heart of adult and pediatric patients. The system also includes the SieClear application. SieClear improves contrast resolution when using linear-type transducers by interrogating the target tissue from different imaging angles and adding these images together to create a composite image. This is performed in real-time.

Source page: https://510kreport.com/device/K083114
Methodology: https://510kreport.com/methodology