# K140854: Intra-Operative Ultrasound Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Aloka Medical, Ltd.
- Decided: Jun 11, 2014 after 69 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: 6 generations back to K954022 (1996). 11 ancestors in all.
1 later device descends 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)
- K122537: Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0, Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical (2013) Summary page 1.

## Most influential descendants
- 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 Hitachi Aloka Medical, Ltd. UST-5310/ UST-5311 transducers for use with the PROSOUND ALPHA6 Diagnostic Ultrasound scanner are intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation during Intra-operative and Intra-operative (Neurosurgery) procedures. The device is not indicated for Ophthalmic applications.

Source page: https://510kreport.com/device/K140854
Methodology: https://510kreport.com/methodology