# K953819: Diagnostic Ultrasound Tranducer

- Pathway: 510(k) (Traditional)
- Applicant: Biosound, Inc.
- Decided: Mar 1, 1996 after 199 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 K884644 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884644: Addit. Trans. Eup-B31/033J/V33/U33/032T/L33/U322, Hitachi Medical Corp. of America (1990) Summary page 1.

## Most influential descendants
- K971942: Sled, Finger, Handle (1997), 0 descendants of its own

## Indications for use
The INT13 is a diagnostic ultrasound intraoperative transducer for use in abdominal surgery. The transducer can be used to image abdominal anatomy during abdominal surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels.

Source page: https://510kreport.com/device/K953819
Methodology: https://510kreport.com/methodology