# K012080: SSD-5000 Diagnostic Ultrasound System

- Pathway: 510(k) (Abbreviated)
- Applicant: Aloka Co., Ltd.
- Decided: Aug 29, 2001 after 57 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: 2 generations back to K954022 (1996). 6 ancestors in all.
207 later devices descend from it; 4 cite it directly.
0 of 214 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992663: Aloka SSD-5500 Diagnostic Ultrasound System, Aloka Co., Ltd. (1999) Summary page 2.
- K002784: Aloka Ust-5280-5, Aloka Co., Ltd. (2000) Summary page 2.
- K011315: SSD 5500 with Olympus GF Type UC140P-AL5, Aloka Co., Ltd. (2001) Summary page 2.
- K011457: Aloka SSD-5500 with KI and a-Sma, Aloka Co., Ltd. (2001) Summary page 2.

## Most influential descendants
- K063500: DC-6 Diagnostic Ultrasound System (2006), 189 descendants of its own
- K072164: DC-6 Diagnostic Ultrasound System (2007), 188 descendants of its own
- K080640: M5 Diagnostic Ultrasound System (2008), 182 descendants of its own
- K081320: DC-3, DC-3T Diagnostic Ultrasound System (2008), 180 descendants of its own
- K083001: M5 Diagnostic Ultrasound System (2008), 179 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/K012080
Methodology: https://510kreport.com/methodology