# K121699: Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 22, 2012 after 14 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). 137 ancestors in all.
98 later devices descend from it; 7 cite it directly.
0 of 236 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090276: Acuson X300 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2009) Summary page 1.
- K093531: Acuson Model X300 Diagnostic Ultrasound System, Siemens Medi Cal Solutions, Inc. (2009) 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.

## Most influential descendants
- K123622: Acuson (2012), 96 descendants of its own
- K123001: Acuson X700 Diagnstic Ultrasound System (2012), 74 descendants of its own
- K132804: Acuson S1000 / S2000 / S3000 (2013), 73 descendants of its own
- K140959: Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems (2014), 60 descendants of its own
- K142876: ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems (2014), 58 descendants of its own

## Indications for use
The Siemens Acuson X300 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. 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. 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 Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

Source page: https://510kreport.com/device/K121699
Methodology: https://510kreport.com/methodology