# K043196: Aloka SSD-Alpha 10 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Aloka Co., Ltd.
- Decided: Nov 30, 2004 after 12 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: 3 generations back to K954022 (1996). 7 ancestors in all.
106 later devices descend from it; 4 cite it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032875: Aloka Model SSD-5500 V6.0 Ultrasound System, Aloka Co. Ltd USA (2003) Summary page 1.

## Most influential descendants
- K110207: Aloka Prousound F75 Diagnostic Ultrasound System (2011), 91 descendants of its own
- K123828: Prosound F75 Diagnostic Ultrasound System (2013), 87 descendants of its own
- K140639: Prosound F75  Diagnostic Ultrasound System (2014), 60 descendants of its own
- K153539: RS80A Diagnostic Ultrasound System (2016), 59 descendants of its own
- K163691: HS70A Diagnostic Ultrasound System (2017), 58 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/K043196
Methodology: https://510kreport.com/methodology