Address:4 rue du Dauphine,Vaulx en Velin Rhone,FR
Device Description : The Ablapak is he single use kit of consumables to support a single patient proc The Ablapak is he single use kit of consumables to support a single patient procedure using the Ablatherm Integrated Imaging system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
Device Class : 2
Duns Number: 383113362
Premarket Exempt : No
Prescription Use : Yes
Device Description : The SONOLITH® electrode is the consumable/ disposable component for the SONOLIT The SONOLITH® electrode is the consumable/ disposable component for the SONOLITH® 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.
Device Class : 2
Duns Number: 383113362
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device is a computer-controlled medical device intended to provide High Inte The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The Focal One system consists of the following main sub-assemblies: Focal One Control Module, Dynamic Focal Probe, and consumable Focalpak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.Imported diagnostic data can be fused with the real time ultrasound image in order to facilitate the targeting of the ablation volume.
Device Class : 2
Duns Number: 383113362
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Focalpak is the single use kit of consumables to support a single patient pr The Focalpak is the single use kit of consumables to support a single patient procedure using the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
Device Class : 2
Duns Number: 383113362
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Ablatherm Endorectal Probe is a primary component of the Ablatherm Integrate The Ablatherm Endorectal Probe is a primary component of the Ablatherm Integrated Imaging system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
Device Class : 2
Duns Number: 383113362
Premarket Exempt : No
Prescription Use : Yes
Device Description : One piece carbon fiber table for use with SONOLITH® i-move or i-sys lithotripsy One piece carbon fiber table for use with SONOLITH® i-move or i-sys lithotripsy devices for ESWL(Extracorporeal Shock Wave Lithotnpsy).
Device Class : 2
Duns Number: 383113362
Premarket Exempt : No
Prescription Use : No
Device Description : A table for use with the SONOLITH® i-move medical device is a lithotripter of ES A table for use with the SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy).
Device Class : 2
Duns Number: 383113362
Premarket Exempt : No
Prescription Use : No
Device Description : SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal S SONOLITH® i-move 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.
Device Class : 2
Duns Number: 383113362
Premarket Exempt : No
Prescription Use : Yes
Device Description : SONOLITH® i-move Visio-Track medical device is a lithotripter of ESWL type (Extr 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.
Device Class : 2
Duns Number: 383113362
Premarket Exempt : No
Prescription Use : No
Device Description : SONOLITH® i-move Touch medical device is a lithotripter of ESWL type (Extracorpo SONOLITH® i-move Touch 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.
Device Class : 2
Duns Number: 383113362
Premarket Exempt : No
Prescription Use : No