# K981510: Sonoace 6000/ Ultramark 400

- Pathway: 510(k) (Traditional)
- Applicant: Medison America, Inc.
- Decided: May 8, 1998 after 10 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: 1 generation back to K924432 (1993). 2 ancestors in all.
212 later devices descend from it; 2 cite it directly.
0 of 215 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924432: Medison 1500, Medison Co., Ltd. (1993) Summary page 1.
- K961459: Level 10 Hdi, Advanced Technology Laboratories, Inc. (1997) Summary page 1.

## Most influential descendants
- K990970: Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called Ultrasound System and Transducers (1999), 209 descendants of its own
- K002185: Sonoace SA 9900 Diagnostic Ultrasound System (2000), 207 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K981510
Methodology: https://510kreport.com/methodology