# K953759: Diagnostic Ultrasound Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Biosound, Inc.
- Decided: Mar 1, 1996 after 203 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: 1 generation back to K925486 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925486: Ust-5522-7.5 & Ust-5522L-7.5 Intraoperative Trans., Aloka Co., Ltd. (1993) Summary page 1.

## Indications for use
The LP13 is a diagnostic ultrasound transducer for use in laparoscopic surgery. The transducer can be used to image abdominal anatomy during laparoscopic surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels

Source page: https://510kreport.com/device/K953759
Methodology: https://510kreport.com/methodology