# K100204: Sonalis

- Pathway: 510(k) (Traditional)
- Applicant: Smith Associates
- Decided: Feb 19, 2010 after 25 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 K993092 (2000). 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)
- K043189: Sonalis, Model 2000, 3g Ultrasound, Inc. (2005) Summary page 1.

## Indications for use
The SONALIS® system and transducers are intended for diagnostic ultrasound imaging of the human body. The clinical application is trans-rectal imaging. Typical examination using the SONALIS® Platform system: Prostate and Rectal wall studies.

Source page: https://510kreport.com/device/K100204
Methodology: https://510kreport.com/methodology