# K122537: Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
- Decided: Apr 12, 2013 after 235 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: 5 generations back to K954022 (1996). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072285: Aloka SSD-Alpha 7 Ultrasound System, Aloka Co., Ltd. (2007) Summary page 1.
- K032875: Aloka Model SSD-5500 V6.0 Ultrasound System, Aloka Co. Ltd USA (2003) Summary page 27.
- K110207: Aloka Prousound F75 Diagnostic Ultrasound System, Aloka Co., Ltd. (2011) Summary page 51.

## Cited in the summary but kept off the family tree
- K011208: Biover, Biover AG (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K140854: Intra-Operative Ultrasound Transducer (2014), 1 descendant of its own
- K142618: Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System (2014), 0 descendants of its own

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Intra-operative (Neuro), Laparoscopic, Pediatric, Neonatal Cephalic, Trans-rectal & vaginal, Musculoskeletal, Gynecological, Cardiac (Adult, Neonatal, Pediatric), TEE & Peripheral Vascular. The device is not intended for ophthalmic applications.

Source page: https://510kreport.com/device/K122537
Methodology: https://510kreport.com/methodology