# K002185: Sonoace SA 9900 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Medison America, Inc.
- Decided: Aug 1, 2000 after 13 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: 3 generations back to K924432 (1993). 10 ancestors in all.
207 later devices descend from it; 5 cite it directly.
0 of 218 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940942: Combison 530 Diagnostic Ultrasound Scanner, Medison America, Inc. (1997) Summary page 2.
- K992155: Volusion Small Parts Transducer, Model S-VNW 5-10, Volusion Abdominal Transducer, Model S-Vaw 4-7, Medison America, Inc. (1999) Summary page 2.
- K974269: SA8800 Diagnostic Ultrasound System and Transducers,, Medison America, Inc. (1998) Summary page 2.
- K990970: Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called Ultrasound System and Transducers, Medison America, Inc. (1999) Summary page 2.
- K992470: Ultramark 400C/Sonoace 6000 Ultrasound System, Advanced Technology Laboratories, Inc. (1999) Summary page 2.

## Most influential descendants
- K013627: Sonoace SA-8000 Diagnostic Ultrasound System (2001), 204 descendants of its own
- K031552: Mycolor 202 Diagnostic Ultrasound System and Transducers (2003), 184 descendants of its own
- K043455: SA8000 SE Diagnostic Ultrasound System (2004), 182 descendants of its own
- K032329: SA 9900 Plus Diagnostic Ultrasound System (2003), 132 descendants of its own
- K052911: Accuvix XQ Diagnostic Ultrasound System (2005), 131 descendants of its own

## Recalls of this device
- Sep 10, 2004 · Not classified · Z-0178-05: Potential for device to cause burning of the skin.

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

Source page: https://510kreport.com/device/K002185
Methodology: https://510kreport.com/methodology