# K072285: Aloka SSD-Alpha 7 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Aloka Co., Ltd.
- Decided: Aug 30, 2007 after 14 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K954022 (1996). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043196: Aloka SSD-Alpha 10 Ultrasound System, Aloka Co., Ltd. (2004) Summary page 1.

## Most influential descendants
- K122537: Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0 (2013), 2 descendants of its own
- 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 (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal /Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Urology (including prostate), Transesophageal, Transrectal, Transvaginal and Intraoperative (abdominal, thoracic & vascular). The Aloka SSD-Alpha 7 is not indicated for ophthalmic applications.

Source page: https://510kreport.com/device/K072285
Methodology: https://510kreport.com/methodology
