# K040741: Ultrasound Localization System Uls 0142

- Pathway: 510(k) (Traditional)
- Applicant: Hmt High Medical Technologies AG
- Decided: Aug 19, 2004 after 149 days
- Product code: LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5990
- 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) LithoTron ULS 0132: named in the summary without a submission number

## Indications for use
The ULS0142 accessory is indicated for localization of a target stone prior to extracorporeal shock wave lithotripsy with the LithoDiamond LTFS230. The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications.

Source page: https://510kreport.com/device/K040741
Methodology: https://510kreport.com/methodology