# K984562: Vivosonic

- Pathway: 510(k) (Traditional)
- Applicant: Sonotech, Inc.
- Decided: Jun 8, 1999 after 167 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K013701: Endo-Glide (2002), 0 descendants of its own

## Indications for use
Used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient and the medical imaging electronics, and to lubricate the insertion and passage of imaging devices. Used in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, endocavity ultrasound imaging and ophthalmic ultrasound imaging. Intended for use in all diagnostic ultrasound procedures which currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polyethylene transducer cover where sterility and in vivo biocompatibility are required.

Source page: https://510kreport.com/device/K984562
Methodology: https://510kreport.com/methodology