# K061980: Siemens Acuson X500 Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 17, 2006 after 35 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
No predicates in its family tree.
425 later devices descend from it; 3 cite it directly.
0 of 426 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Siemens Sonoline G60S ultrasound system: named in the summary without a submission number

## Most influential descendants
- K083149: Arterial Health Package (Ahp) Software (2009), 330 descendants of its own
- K090276: Acuson X300 Diagnostic Ultrasound System (2009), 277 descendants of its own
- K072090: Siemens Diagnostic Ultrasound Systems (2007), 189 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

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

Source page: https://510kreport.com/device/K061980
Methodology: https://510kreport.com/methodology