510(k) K231378 ยท PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0
| Applicant | Insightec, Ltd., Tirat-Hacarmet, IL |
| Decision | Substantially Equivalent, Oct 30, 2023 |
| Received | May 12, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231378
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.