Sonolith I-Move Visio-Track Module
SONOLITH® i-move Visio-Track medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which…
SONOLITH® i-move Visio-Track medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which are focalized on the stone to be treated, at fixed frequency or patient synchronized frequency.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Wikkon Precision Technologies Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Edap TMS France SA, France |
|---|---|
| FDA product code | LNS |
| Device type | Lithotriptor, Extracorporeal Shock-Wave, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5990 |
| Establishment | Remanufacturer, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K111808 |
| Record published | 2016-09-21 |
| Record revised | 2024-12-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-05-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TMS 239271 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Piezolith 3000 Triple-Focus Lithotripsy System Complete | United Medical Systems (DE), Inc. | 47 |
| Piezolith 3000 Triple-Focus Lithotripsy System Complete | United Service Solutions, LLC | 46 |
| Modulith® | Storz Medical AG | 8 |
| Dornier MedTech | Dornier Medtech Gmbh | 6 |
| Econolith EM1000 | Medispec, Ltd. | 5 |
| Econolith E3000 | Medispec, Ltd. | 2 |
| Dornier Delta III | Dornier Medtech Gmbh | 2 |
| Piezolith | Richard Wolf Gmbh | 2 |
| Sonolith i-move Standard Module | Edap TMS France SA | 1 |
| Compact Duet | Direx Systems Corp. | 1 |
| ASADAL-M1 | Huons Co., Ltd. | 1 |
| Econolith E2000 | Medispec, Ltd. | 1 |
Showing 12 of 20. All products under Lithotriptor, Extracorporeal Shock-Wave, Urological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111808 | 2011-08-01 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P870018 | 1999-04-30 | LITHOSTAR MULTILINE | Siemens Healthcare Limited |
| P970019 | 1998-07-14 | HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM | Healthtronics Surgical Services, Inc. |
| P970062 | 1998-06-24 | GENESTONE 190 LITHOTRIPTER | Bmt, Inc. |
| P950043 | 1998-05-21 | ECONOLITH(TM) LITHOTRIPTER | Medispec, Ltd. |
| P870015 | 1998-03-05 | MEDSTONE STS(TM) LITHOTRIPTER | Medstone Intl., Inc. |
| P920034 | 1997-03-26 | TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS | Medirex, Inc. |
| P920051 | 1996-06-21 | STORZ MODULITH LITHOTRIPTER, MODEL SLX | Karl Storz Endoscopy-America, Inc. |
| P840008 | 1995-10-05 | DORNIER LITHOTRIPTER TRANSPORTABLE (DLT) | Dornier Medtech America, Inc. |
| P890066 | 1994-04-18 | THERASONIC LITHOTRIPSY TREATMENT SYSTEM | Focus Surgery, Inc. |
| P880042 | 1994-04-18 | EDAP LT.01 SHOCK WAVE LITHOTRIPTER | Edap International Corp. |
| P880011 | 1992-02-10 | TECHNOMED INTERNATIONAL SONOLITH 3000 (LITHORAY)TM | Edap International Corp. |
| P890013 | 1991-09-09 | RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 | Richard Wolf Medical Instruments Corp. |
| P870011 | 1990-09-06 | HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE | Towers Perrin |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.