# K120156: Pureimage Ultrasound Transmission Gel

- Pathway: 510(k) (Traditional)
- Applicant: Medline
- Decided: Feb 8, 2012 after 21 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Purelmae TM Sterile Ultrasound Transmission Gel is intended for use as the coupling medium for ultrasound procedures where sterility of the ultrasound transmission gel is preferred. The Purelmage TM Sterile Ultrasound Transmission Gel is intended for use with imaging procedures only. As such it is indicated for use with transabdominal or transvaginal ultrasound diagnostic procedures. Contraindications: Not for use with defibrillators.

Source page: https://510kreport.com/device/K120156
Methodology: https://510kreport.com/methodology