# K041916: Aloka SSD-Alpha 5 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Aloka Co. Ltd USA
- Decided: Jul 30, 2004 after 14 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 K954022 (1996). 7 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032875: Aloka Model SSD-5500 V6.0 Ultrasound System, Aloka Co. Ltd USA (2003) Summary page 2.

## Most influential descendants
- K070983: Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10 Ultrasound System (2007), 11 descendants of its own
- K081518: Ultrasound Video Bronchoscope, Model EB-1970UK (2008), 5 descendants of its own
- K131946: Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin Preirus (2014), 3 descendants of its own
- K183525: EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F (2019), 2 descendants of its own
- K203128: Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2 Premier Plus (2020), 1 descendant of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K041916
Methodology: https://510kreport.com/methodology