# K070665: Lithoskop

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 4, 2008 after 298 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.
5 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Dorier Lithotripter S: named in the summary without a submission number

## Most influential descendants
- K103217: Lite-Med LM-9200 Elma (2011), 4 descendants of its own
- K142561: LM-9300 ELMA Lithotripter (2015), 1 descendant of its own
- K242922: Extracorporeal Shock Wave Lithotripter (U200) (2025), 0 descendants of its own
- K201001: Modulith SLX-F2 (2021), 0 descendants of its own
- K131721: Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1 (2014), 0 descendants of its own

## Indications for use
LITHOSKOP is a urologic procedures system primarily designed for the fragmentation of urinary tract stones, such as renal calyx stones and renal pelvis stones and for upper, middle and lower ureteral stones by extracorporeal shock wave lithotripsy (ESWL). In addition to ESWL use, the unit is designed for patient placement in positions which facilitate urological and diagnostic procedures.

Source page: https://510kreport.com/device/K070665
Methodology: https://510kreport.com/methodology