# K121646: Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc. Ultrasound Gro
- Decided: Jun 22, 2012 after 17 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: 15 generations back to K935595 (1995). 128 ancestors in all.
No later device cites it as a predicate yet.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081121: Modification to Acuson X150 Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2008) Summary page 1.
- K113179: Acuson SC2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2011) Summary page 1.
- K101091: Z.One Ultra Ultrasound System, Zonare Medical Systems, Inc. (2010) Summary page 1.
- K113690: GE Logiq I, Logiq E and Vivid E, GE Healthcare (2011) Summary page 1.
- K014206: Logiqbook, General Electric Co. (2002) Summary page 1.
- K101757: Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System, Sonosite,Inc. (2010) Summary page 1.

## Indications for use
The Siemens Acuson X1 50 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Source page: https://510kreport.com/device/K121646
Methodology: https://510kreport.com/methodology