# K011457: Aloka SSD-5500 with KI and a-Sma

- Pathway: 510(k) (Traditional)
- Applicant: Aloka Co., Ltd.
- Decided: May 23, 2001 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
No predicates in its family tree.
331 later devices descend from it; 3 cite it directly.
0 of 332 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012080: SSD-5000 Diagnostic Ultrasound System (2001), 207 descendants of its own
- 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

Source page: https://510kreport.com/device/K011457
Methodology: https://510kreport.com/methodology