# K072676: Acuson X300 Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 18, 2007 after 88 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K935595 (1995). 40 ancestors in all.
279 later devices descend from it; 3 cite 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)
- K071036: Modification to Acuson X300 Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2007) Summary page 6.
- K061946: Acuson X300 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.

## Most influential descendants
- K080760: Acuson X300 Ultrasound System (2008), 278 descendants of its own
- 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

## Recalls of this device
- Aug 17, 2010 · Not classified · Z-1838-2011: There is an error in the estimation of mean pressure gradient in the Cardiac measurement package. The currently implemented calculation will result in an underestimation of the mean pressure gradient 
- Jul 30, 2009 · Not classified · Z-2065-2011: Software Error with potential for misinterpretation of data-- The previous patient's last capture clip image can appear in the next patient's study.
- Jul 24, 2009 · Not classified · Z-2061-2011: Product Failure-- When the 64-Channel System V5M is used in the 128-Channel mode, an over current fault occurs which shuts the system down.
- Jul 24, 2009 · Not classified · Z-2147-2011: Mistreatment risk-- when a user defined formula is used to calculate a value in a vascular exam, data is switched laterally when it is internally transferred and displayed on the summary report within
- Aug 19, 2008 · Not classified · Z-0111-2009: Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the C8-5 transducer. This is a required display to support the alara principle when imaging cranial structure.

## 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/K072676
Methodology: https://510kreport.com/methodology