# K080760: Acuson X300 Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc., Ultrasound DI
- Decided: Apr 25, 2008 after 38 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: 11 generations back to K935595 (1995). 41 ancestors in all.
278 later devices descend from it; 1 cites it directly.
0 of 320 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.

## Most influential descendants
- K090276: Acuson X300 Diagnostic Ultrasound System (2009), 277 descendants of its own
- 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

## 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.

Source page: https://510kreport.com/device/K080760
Methodology: https://510kreport.com/methodology