FDA.reportPublic FDA data

Sonolith i-move Visio-Track Module

Primary DI
03661690000113
Brand
Sonolith i-move Visio-Track Module
Company
EDAP-TMS FRANCE
Model
TMS 239271
Catalog number
TMS 239271
Device description
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.
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNSLithotriptor, Extracorporeal Shock-Wave,Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNSLithotriptor, Extracorporeal Shock-Wave, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111808000SONOLITH I-MOVEEdap Tms France2011-08-01LNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661690000113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661690000113036616900001133661690000113

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical lithotripsy system, extracorporealAn assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by an electromechanical generator. This generator contains a coil attached to a thin metallic membrane; a magnetic field is produced by an electric current conducted through the coil, and shock waves are generated when the metallic membrane is repelled by the magnetic field. The system also includes a treatment table, an imaging system, and an operator's console. This [extracorporeal shock wave lithotripsy (ESWL)] system is used to disintegrate stones located in the kidneys, urinary tract, gallbladder, or bile/pancreatic ducts.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(512) 832-7956mhull@edap-usa.com

Regulatory Flags#

DUNS number
383113362
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661690000267Focal OneTMS 2347802026-01-26
03661690000342Endorectal ProbeTMS 2537282026-01-26
03661690000014AblapakTMS 2277102018-06-08
03661690000076Ablatherm Endorectal ProbeEDP 900900EDP 9009002018-06-08
03661690000083Sonolith Carbon Fiber TableTMS 230811TMS2308112016-09-21
03661690000090Endo-i-move TableTMS 233101TMS2331012016-09-21
03661690000106Sonolith i-move Standard ModuleTMS 239269TMS 2392692016-09-21
03661690000120Sonolith i-move Touch ModuleTMS 239270TMS 2392702016-09-21
03661690000144Ablatherm Integrated ImagingEDP9008002016-09-21
03661690000151Carbon Fiber Table W2ETMS 234181TMS 2341812016-09-23
03661690000199ABLATHERM FUSIONEDP 9008002018-02-23
03661690000069FocalpakTMS 239305TMS 2393052018-06-11
03661690000243FocalPakEDP 901400EDP 9014002021-03-04
03661690000052Focal OneTMS 2393202018-06-11
03661690000045Sonolith ElectrodeTMS 220830TMS2208302018-06-08
03661690000205Dynamic Focal ProbeTMS 902081TMS 9020812018-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974928350131Extracorporeal Shock Wave LithotripterShenzhen Wikkon Precision Technologies Co., Ltd.LNS2025-07-30
08800089800483ASADAL-M1Huons Meditech Co., Ltd.LNS2025-05-26
07630039101442MODULITH®Storz Medical AGLNS2025-04-11
07630039101459MODULITH®Storz Medical AGLNS2025-04-11
07630039101466MODULITH®Storz Medical AGLNS2025-04-11
06975438931018Extracorporeal Shock Wave LithotripterSuzhou Xixin Medical Instruments Co., Ltd.LNS2023-12-25
04049957006464Dornier Delta III Dornier MedTech GmbHLNS2023-03-24
04049957006471Dornier Delta III Dornier MedTech GmbHLNS2023-03-24
07630039100919MODULITH®Storz Medical AGLNS2021-04-13
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00810000980666PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
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