# K964549: Aloka Ust-5258-5 Diagnostic Ultrasound Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Aloka Co., Ltd.
- Decided: Jun 3, 1997 after 202 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Aloka UST-5228-5 diagnostic ultrasound transducer: named in the summary without a submission number

## Indications for use
Diagnostic ultraseund-imaging and Doppler analysis of the human body.. Medical disciplines that use transesophageal diagnostic ultrasound include Cardiology, Surgery and Trauma.

Source page: https://510kreport.com/device/K964549
Methodology: https://510kreport.com/methodology