# K012887: SA6000II Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Medison America, Inc.
- Decided: Sep 12, 2001 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: 4 generations back to K924432 (1993). 12 ancestors in all.
32 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992761: Sonoace 5500 Diagnostic Ultrasound System, Medison America, Inc. (1999) Summary page 1.
- K002185: Sonoace SA 9900 Diagnostic Ultrasound System, Medison America, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K083882: Mylabfive (2009), 26 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:

Source page: https://510kreport.com/device/K012887
Methodology: https://510kreport.com/methodology