# K040719: Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Aloka Co., Ltd.
- Decided: Mar 26, 2004 after 7 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). 8 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003739: Aloka SSD-4000, Aloka Co., Ltd. (2000) Summary page 1.
- K992663: Aloka SSD-5500 Diagnostic Ultrasound System, Aloka Co., Ltd. (1999) Summary page 1.
- K002784: Aloka Ust-5280-5, Aloka Co., Ltd. (2000) Summary page 1.
- K011457: Aloka SSD-5500 with KI and a-Sma, Aloka Co., Ltd. (2001) Summary page 1.
- K011315: SSD 5500 with Olympus GF Type UC140P-AL5, Aloka Co., Ltd. (2001). Our reading of the summary gave K001315, FDA’s number for Modification to Kion Anesthesia System (Siemens Elema AB). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Aloka SSD-5500 Ver. 4.2.2”.
- K032875: Aloka Model SSD-5500 V6.0 Ultrasound System, Aloka Co. Ltd USA (2003) Summary page 1.

## Most influential descendants
- K110688: Mylabgold (2011), 25 descendants of its own
- K132231: Mylabseven, Mylabalpha (2013), 22 descendants of its own
- K142008: Mylabseven, Mylabalpha (2014), 19 descendants of its own
- K153277: 6200 Ultrasound System and 6250 Ultrasound System (2016), 12 descendants of its own
- K163082: 6200 Ultrasound System and 6250 Ultrasound System (2017), 9 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/K040719
Methodology: https://510kreport.com/methodology