# K142618: Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Hitachi Aloka Medical America, Inc.
- Decided: Oct 16, 2014 after 30 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: 7 generations back to K954022 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140854: Intra-Operative Ultrasound Transducer, Hitachi Aloka Medical, Ltd. (2014) Summary page 4.

## Indications for use
The Hitachi Aloka Medical, Ltd UST-5310 or UST-5310-TIP / UST-5311 or UST-5311-TIP transducers are intended for use with the PROSOUND ALPHA 6, PROSOUND ALPHA 7 and ARIETTA70 Diagnostic Ultrasound systems by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation during intra-operative and Intra-operative (neurosurgery) procedures. This device is not indicated for Ophthalmic applications.

Source page: https://510kreport.com/device/K142618
Methodology: https://510kreport.com/methodology