# K080176: Aloka Prosound 6 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Aloka Co., Ltd.
- Decided: Feb 29, 2008 after 36 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: 1 generation back to K972465 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972465: Aloka SSD-1400 Diagnostic Ultrasound System, Aloka Co., Ltd. (1997) Summary page 1.

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Peripheral Vascular, Transrectal, Transvaginal and Intraoperative (abdominal, thoracic & vascular) applications. The device is not indicated for Ophthalmic applications.

Source page: https://510kreport.com/device/K080176
Methodology: https://510kreport.com/methodology