# K020668: Aloka SSD-1000 Diagnostic Ultrasound System, Models Asu-1003, Ust-9121, Ust-9124

- Pathway: 510(k) (Abbreviated)
- Applicant: Aloka Co., Ltd.
- Decided: Jul 10, 2002 after 131 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 K954022 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012253: SSD-1000 Diagnostic Ultrasound System, Aloka Co., Ltd. (2001)
- K012080: SSD-5000 Diagnostic Ultrasound System, Aloka Co., Ltd. (2001)

## Indications for use
The transducers are to be used for diagnostic ultrasound imaging in Urological, Abdominal, Intraoperative, Surgical and Endoscopic applications.

Source page: https://510kreport.com/device/K020668
Methodology: https://510kreport.com/methodology