# K061213: Sonoace Pico Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Medison Co., Ltd.
- Decided: May 16, 2006 after 14 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: 7 generations back to K924432 (1993). 14 ancestors in all.
114 later devices descend from it; 3 cite it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013627: Sonoace SA-8000 Diagnostic Ultrasound System, Medison America, Inc. (2001) Summary page 1.
- K043455: SA8000 SE Diagnostic Ultrasound System, Medison Co., Ltd. (2004) Summary page 1.

## Most influential descendants
- K100186: Mysono U5 Diagnostic Ultrasound System (2010), 111 descendants of its own
- K102065: Sonoace R7 Diagnostic Ultrasound System (2010), 110 descendants of its own
- K112646: Sonoace R7 Diagnostic Ultrasound System (2011), 108 descendants of its own
- K101829: The Sonoace R3 Diagnostic Ultrasound System (2010), 104 descendants of its own
- K103722: The Sonoace R5 Diagnostic Ultrasound System (2011), 103 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/K061213
Methodology: https://510kreport.com/methodology