# K090276: Acuson X300 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 19, 2009 after 15 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K935595 (1995). 51 ancestors in all.
277 later devices descend from it; 3 cite it directly.
0 of 329 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080760: Acuson X300 Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2008) Summary page 1.
- K072676: Acuson X300 Ultrasound System, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K071036: Modification to Acuson X300 Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2007) Summary page 1.
- K061946: Acuson X300 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.
- K050240: Modification to Acuson CV70 Cardiovascular System, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K063085: Modification to Acuson Sequoia Ultrasound System, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.
- K083149: Arterial Health Package (Ahp) Software, Siemens Medical Solutions USA, Inc. (2009) Summary page 1.

## Most influential descendants
- K092691: DC-7 Diagnostic Ultrasound System (2009), 176 descendants of its own
- K100830: M7/M7T Diagnostic Ultrasound System (2010), 138 descendants of its own
- K101041: DC-7 Diagnostic Ultrasound System (2010), 130 descendants of its own
- K102991: M5 Diagnostic Ultrasound System (2010), 128 descendants of its own
- K103677: M7/M7T Diagnostic Ultrasound System (2011), 123 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 meas'ement of.anatomical structuresand-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/K090276
Methodology: https://510kreport.com/methodology