| Primary Device ID | 03661690000144 |
| NIH Device Record Key | 7a37bc0d-100a-4adf-993d-d43708b181d8 |
| Commercial Distribution Discontinuation | 2019-12-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Ablatherm Integrated Imaging |
| Version Model Number | EDP900800 |
| Company DUNS | 383113362 |
| Company Name | EDAP-TMS FRANCE |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
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| 03661690000144 - Ablatherm Integrated Imaging | 2024-12-11The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The system consists of the following main sub-assemblies: Therapy Control Module, Treatment Module, Endorectal Probe, and consumable Ablapak. 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. |
| 03661690000144 - Ablatherm Integrated Imaging | 2024-12-11 The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HI |