# K083614: Sonolith I-Sys Lithotriper

- Pathway: 510(k) (Abbreviated)
- Applicant: Technomed Medical Systems, SA
- Decided: Jul 27, 2009 after 231 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
Longest line of descent: 2 generations back to P840008 (1984). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003529: Sonolith Praktis, Endourology Table Praktis, Edap Technomed, Inc. (2001) Summary page 2.
- K011873: Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP), Dornier (2001) Summary page 2.

## Most influential descendants
- K111808: Sonolith I-Move (2011), 0 descendants of its own

## Indications for use
The Sonolith I sys is intended to fragment stones in the kidney (renal pelvis and renal calyces) and the ureter (upper, middle and lower ureter) The Endourology table I-sys table is intended for urological diagnostics, endourological interventions (e.g. TURP) extracorporeal lithotripsy in conjunction with the diagnostic and therapeutic module of the platform.

Source page: https://510kreport.com/device/K083614
Methodology: https://510kreport.com/methodology