# K012867: Sonoace 9900 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Medison America, Inc.
- Decided: Sep 12, 2001 after 16 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: 2 generations back to K961459 (1997). 2 ancestors in all.
132 later devices descend from it; 1 cites it directly.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974269: SA8800 Diagnostic Ultrasound System and Transducers,, Medison America, Inc. (1998) Summary page 1.

## Most influential descendants
- K052911: Accuvix XQ Diagnostic Ultrasound System (2005), 131 descendants of its own
- K063580: Sonoace X8 Diagnostic Ultrasound System (2006), 129 descendants of its own
- K070813: Accuvix V10 Diagnostic Ultrasound System (2007), 125 descendants of its own
- K080800: Accuvix V20 Diagnostic Ultrasound System (2008), 124 descendants of its own
- K092159: Accuvix V20 Diagnostic Ultrasound System (2009), 123 descendants of its own

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

Source page: https://510kreport.com/device/K012867
Methodology: https://510kreport.com/methodology