# K020956: Vivosonic Dianostic Ultrasound Imaging Coupling Media

- Pathway: 510(k) (Traditional)
- Applicant: Microtek Medical, Inc.
- Decided: May 16, 2002 after 52 days
- Product code: MUI (Media, Coupling, Ultrasound)
- 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) Aquasonic 100 sterile: named in the summary without a submission number
- (no number) Ultra/Phonic sterile: named in the summary without a submission number
- (no number) Natural Image: named in the summary without a submission number

## Indications for use
VivoSonic Media is 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. VivoSonic Media is used in conjunction with transcutaneous ultrasound imaging guided biopsy and apsiration, intraoperative ultrasound imaging, endocavity ultrasound imaging, and opthalmic ultrasound imaging. VivoSonic Media is intended for use in all diagnostic ultrasound procedures which currently use an ultrasound gel or fluid alone or in combination with a latex, non-latex, polyurethane or polyethylene transducer cover where sterility and vivo biocompatibility are required.

Source page: https://510kreport.com/device/K020956
Methodology: https://510kreport.com/methodology