# K992761: Sonoace 5500 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Medison America, Inc.
- Decided: Sep 1, 1999 after 15 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K924432 (1993). 7 ancestors in all.
33 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990970: Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called Ultrasound System and Transducers, Medison America, Inc. (1999) Summary page 1.
- K974813: Combison 530D with Power Doppler Mode, Medison America, Inc. (1998) Summary page 1.

## Most influential descendants
- K012887: SA6000II Diagnostic Ultrasound System (2001), 32 descendants of its own
- K043588: Mylab 15 / Mylab 20, Model 2700 (2005), 30 descendants of its own
- K053154: MYLAB15/20 3D/4D Ultrasound Imaging System (2005), 29 descendants of its own
- K061755: MYLAB15/20 New Indications Ultrasound System (2006), 28 descendants of its own
- K070903: MYLAB40 (2007), 27 descendants of its own

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

Source page: https://510kreport.com/device/K992761
Methodology: https://510kreport.com/methodology