510(k) K153023 ยท PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Ablatherm Integrated Imaging
| Applicant | Edap Technomed, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Nov 6, 2015 |
| Received | Oct 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153023
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2017 | Edap Technomed Inc. Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation
Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue Terminated |
PLP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.