# K981028: Ultra Image and Ultra Scan

- Pathway: 510(k) (Traditional)
- Applicant: Sonotech, Inc.
- Decided: Aug 21, 1998 after 155 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 K883917 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883917: Natural Image Ultrasound Transmission Couplant, Sonomed Technology, Inc. (1989) Summary page 2.
- K931909: Clear Image Sterile Diagnostic Ultrsound Gel, Sonomed Technology, Inc. (1994) Summary page 2.
- K931908: Sonoquick Ultrasound Gel, Sonomed Technology, Inc. (1994) Summary page 2.

## Indications for use
Sono Image and Ultra Glide are coupling gels and will be used in conjunction with ultrasound transducers during medical diagnostic ultrasound to couple sound waves into the patient's body. Sono Image is a high viscosity scanning gel suitable for echocardiography, vascular sonography, vascular sonography and general ultrasound scanning procedures. Ultra Glide is a low viscosity scanning gel suitable for abdominal, OB/GYN and general ultrasound scanning procedures. Note: viscosity does not affect the safety or performance of a scanning gel. Scanning gels are selected by sonographers based on viscosity preference.

Source page: https://510kreport.com/device/K981028
Methodology: https://510kreport.com/methodology