# K061946: Acuson X300 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 21, 2006 after 11 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K935595 (1995). 38 ancestors in all.
428 later devices descend from it; 6 cite it directly.
0 of 467 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050034: Sonoline Antares Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K052894: Sonoline G60 S Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K043016: Sonoline Orchid Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K042044: Acuson CV70 Cardiovascular System, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.

## Most influential descendants
- K071036: Modification to Acuson X300 Ultrasound System (2007), 427 descendants of its own
- K083149: Arterial Health Package (Ahp) Software (2009), 330 descendants of its own
- K072676: Acuson X300 Ultrasound System (2007), 279 descendants of its own
- K080760: Acuson X300 Ultrasound System (2008), 278 descendants of its own
- K090276: Acuson X300 Diagnostic Ultrasound System (2009), 277 descendants of its own

## Recalls of this device
- Aug 19, 2008 · Not classified · Z-0086-2009: Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates.

## Indications for use
Diagnostic imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K061946
Methodology: https://510kreport.com/methodology