# K093531: Acuson Model X300 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Dec 1, 2009 after 15 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: 13 generations back to K935595 (1995). 54 ancestors in all.
99 later devices descend from it; 1 cites it directly.
0 of 154 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.
- 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.
- K061980: Siemens Acuson X500 Ultrasound System, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.
- K081121: Modification to Acuson X150 Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2008) Summary page 1.

## Most influential descendants
- K121699: Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System (2012), 98 descendants of its own
- 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

## Indications for use
The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoiperative, 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/K093531
Methodology: https://510kreport.com/methodology