# K012253: SSD-1000 Diagnostic Ultrasound System

- Pathway: 510(k) (Abbreviated)
- Applicant: Aloka Co., Ltd.
- Decided: Aug 30, 2001 after 43 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 K972465 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972465: Aloka SSD-1400 Diagnostic Ultrasound System, Aloka Co., Ltd. (1997) Summary page 2.

## Most influential descendants
- K020668: Aloka SSD-1000 Diagnostic Ultrasound System, Models Asu-1003, Ust-9121, Ust-9124 (2002), 0 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/K012253
Methodology: https://510kreport.com/methodology