# K032329: SA 9900 Plus Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Medison America, Inc.
- Decided: Aug 6, 2003 after 8 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: 5 generations back to K924432 (1993). 12 ancestors in all.
132 later devices descend from it; 1 cites it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002185: Sonoace SA 9900 Diagnostic Ultrasound System, Medison America, Inc. (2000) Summary page 2.
- K013627: Sonoace SA-8000 Diagnostic Ultrasound System, Medison America, Inc. (2001) Summary page 2.

## 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
SA-9900PLUS intended uses as defined FDA guidance documents are: Fetal (includes infertility monitoring of follicle development) Abdominal Pediatric Small Organ Adult Cephalic Cardiac (Adult, Pediatric) Trans-Rectal Trans-Vaginal Peripheral-Vascular Muscular-Skeletal (conventional, superficial)

Source page: https://510kreport.com/device/K032329
Methodology: https://510kreport.com/methodology