# K971942: Sled, Finger, Handle

- Pathway: 510(k) (Traditional)
- Applicant: Biosound Esaote, Inc.
- Decided: Jul 23, 1997 after 57 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: 2 generations back to K884644 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953819: Diagnostic Ultrasound Tranducer, Biosound, Inc. (1996) Summary page 1.
- K884644: Addit. Trans. Eup-B31/033J/V33/U33/032T/L33/U322, Hitachi Medical Corp. of America (1990) Summary page 1.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K971942
Methodology: https://510kreport.com/methodology