# K111227: Aloka SSD-3500 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Aloka Co., Ltd.
- Decided: May 13, 2011 after 11 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 K003739 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060059: Aloka SD-3500 Ultrasound System, Aloka Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K152126: Ust-5550-R; Ust-5536-R; L43K (2016), 0 descendants of its own

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intra-operative (Cardiac), Trans-vaginal, Trans-rectal, Gynecological, Pediatric, Laparoscopic, and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications.

Source page: https://510kreport.com/device/K111227
Methodology: https://510kreport.com/methodology